[Senate Hearing 113-836]
[From the U.S. Government Publishing Office]
S. Hrg. 113-836
PROGRESS AND CHALLENGES: THE STATE OF TOBACCO USE AND REGULATION IN THE
UNITED STATES
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED THIRTEENTH CONGRESS
SECOND SESSION
ON
EXAMINING THE STATE OF TOBACCO USE AND REGULATION IN THE UNITED STATES,
FOCUSING ON PROGRESS AND CHALLENGES
__________
MAY 15, 2014
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.gpo.gov/fdsys/
U.S. GOVERNMENT PUBLISHING OFFICE
22-614 PDF WASHINGTON : 2017
_________________________________________________________________________________________
For sale by the Superintendent of Documents, U.S. Government Publishing Office,
http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center,
U.S. Government Publishing Office. Phone 202-512-1800, or 866-512-1800 (toll-free).
E-mail, [email protected]
COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
TOM HARKIN, Iowa, Chairman
BARBARA A. MIKULSKI, Maryland LAMAR ALEXANDER, Tennessee
PATTY MURRAY, Washington MICHAEL B. ENZI, Wyoming
BERNARD SANDERS (I), Vermont RICHARD BURR, North Carolina
ROBERT P. CASEY, JR., Pennsylvania JOHNNY ISAKSON, Georgia
KAY R. HAGAN, North Carolina RAND PAUL, Kentucky
AL FRANKEN, Minnesota ORRIN G. HATCH, Utah
MICHAEL F. BENNET, Colorado PAT ROBERTS, Kansas
SHELDON WHITEHOUSE, Rhode Island LISA MURKOWSKI, Alaska
TAMMY BALDWIN, Wisconsin MARK KIRK, Illinois
CHRISTOPHER S. MURPHY, Connecticut TIM SCOTT, South Carolina
ELIZABETH WARREN, Massachusetts
Derek Miller, Staff Director
Lauren McFerran, Deputy Staff Director and Chief Counsel
David P. Cleary, Republican Staff Director
(ii)
C O N T E N T S
__________
STATEMENTS
THURSDAY, MAY 15, 2014
Page
Committee Members
Harkin, Hon. Tom, Chairman, Committee on Health, Education,
Labor, and Pensions, opening statement......................... 1
Alexander, Hon. Lamar, a U.S. Senator from the State of
Tennessee, opening statement................................... 3
Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode
Island......................................................... 4
Burr, Hon. Richard, a U.S. Senator from the State of North
Carolina....................................................... 4
Witnesses
McAfee, Tim, M.D., MPH, Director, Office on Smoking and Health,
Centers for Disease Control and Prevention, Atlanta, GA........ 6
Prepared statement........................................... 8
Zeller, Mitch, J.D., Director, Center for Tobacco Products, U.S.
Food and Drug Administration, Silver Spring, MD................ 13
Prepared statement........................................... 14
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.:
Response by Mitchell Zeller to questions of:
Senator Harkin............................................... 41
Senator Alexander............................................ 42
Senator Mikulski............................................. 48
Senator Murkowski............................................ 49
Senator Roberts.............................................. 50
Senator Burr................................................. 52
Senator Casey................................................ 56
(iii)
PROGRESS AND CHALLENGES: THE STATE OF TOBACCO USE AND REGULATION IN THE
UNITED STATES
----------
THURSDAY, MAY 15, 2014
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The committee met, pursuant to notice, at 3:35 p.m. in room
SD-430, Dirksen Senate Office Building, Hon. Tom Harkin,
chairman of the committee, presiding.
Present: Senators Harkin, Alexander, Whitehouse, and Burr.
Opening Statement of Senator Harkin
The Chairman. The committee on Health, Education, Labor,
and Pensions will come to order.
I thank everyone for their patience. We just had a whole
lot of votes on the Senate floor.
We have convened this hearing to examine the State of
tobacco use and regulation in the United States, both the
extraordinary public health efforts that have driven down
tobacco use, and the enormous challenges that remain.
Our Nation has made remarkable progress in the 50 years
since the first Surgeon General's Report on Smoking and Health.
In that time, the smoking rate has been cut by more than half,
from 42 percent to 18 percent. We have learned what works, from
smoke-free workplaces to access to free cessation services;
from meaningful tobacco taxes to robust regulation; from media
campaigns like the wildly successful Tips from a Former Smoker
to commonsense marketing restrictions. So, we know what works.
Yet, despite all these efforts and successes, tobacco use
remains the leading preventable cause of death in the United
States. Let me repeat that. Tobacco use remains the No. 1
preventable cause of death in the United States.
Right now, 16 million Americans are suffering from smoking-
caused illness, and 5.6 million kids alive today will
ultimately die from smoking. Today, nearly 1 in 4 high school
seniors smoke and, sadly, most young smokers become adult
smokers.
The problem is not just cigarettes. Last fall, the Centers
for Disease Control and Prevention reported that the use of
electronic cigarettes, or e-cigarettes--and I am going to have
more to say about those after a bit because I have an array of
them up here--among middle and high school students more than
doubled in 1 year.
It is because of statistics like these that public health
efforts to combat tobacco have been among my top priorities
since I came here. In responding to the hundreds of thousands
who die every year due to tobacco use, in 1998 I introduced the
first comprehensive, bipartisan bill--it was bipartisan--to
give the FDA authority to regulate tobacco. It took a while,
but that goal finally became a reality 5 years ago with passage
of the Family Smoking Prevention and Tobacco Control Act.
Today, we want to examine the implementation of that law to
date.
More recently, in light of the fact that some 3,500
children try smoking for the first time each day, I authored
provisions in the Affordable Care Act that ensure every
American has access to tobacco cessation services without co-
pays or deductibles. Also, due to the provisions that I put in
on the Prevention and Public Health Fund, we have invested more
than $300 million in community-based public health efforts to
curb tobacco use.
And last month, confronted with the bleak prospect of a
whole new generation becoming addicted to nicotine by way of e-
cigarettes, I joined with 10 of my colleagues to release an
investigative report revealing that manufacturers are devoting
massive resources to the marketing of e-cigarettes and their
marketing strategies are expressly designed to appeal to kids.
So I urge everyone to read that report.
I want to just share one example of the many graphics it
contains. That is this chart you see up here. It is an animated
cartoon video game through which players earn e-cigarette
coupons to redeem on Facebook. Kids play these games, then they
get on Facebook and they can redeem coupons.
Cartoons, video games, social media, candy flavors. The
ones I have here, let us see, I have Gummy Bear, that is one;
that appeals to adults, right, gummy bear? Then there is one,
Rocket Pop that has a popsicle on the front of it; cotton candy
concentrated nicotine. Now, I have another one here is Cran-
Apple, and I have a strawberry too. I did not want to leave out
strawberry.
It is the same thing we used to see with flavored
cigarettes; same thing. So again, they are pulling out their
stops to target children. It is absolutely shameful. Again, a
throwback, a disgusting throwback, to Big Tobacco's playbook to
promote traditional cigarettes to kids before restrictions were
in place.
I know that some believe that e-cigarettes are a promising
alternative to cigarettes, but hopefully, we can all agree
these products do not belong in the hands of kids. Keep in
mind, this is a drug delivery device. It delivers nicotine.
Nicotine is an addictive drug.
I look forward to hearing more today from FDA about their
new proposal to regulate these e-cigarettes and other tobacco
products under the authority of the Family Smoking and
Prevention Control Act.
What is this one called? Cherry crush; I did not mean to
leave that out either. Cherry crush, that is for the
refillables. You can refill them.
The e-cigarette phenomenon has created a regulatory black
hole that has gone on too long. Today's hearing is Congress'
first examination of that proposal, which has extraordinary
consequences for public health.
We are pleased today to have Dr. Tim McAfee of CDC's Office
on Smoking and Health, and Mr. Mitch Zeller of FDA's Center for
Tobacco Products to talk about the ongoing public health
challenge posed by tobacco. They will also report on the
important community-based and regulatory work in which those
agencies are engaged.
And now, I will turn to Senator Alexander for his opening
statement.
Opening Statement of Senator Alexander
Senator Alexander. Thanks, Mr. Chairman.
Welcome to the witnesses.
Congress passed the law to which Senator Harkin referred,
the Family Smoking Prevention and Tobacco Control Act almost 5
years ago, and it clearly was taking a position to discourage
the use of tobacco products. What has happened since then,
around 18 percent of adults still smoke cigarettes, but that is
down from 20 percent in 2010. Smoking among youth continues to
decline.
Electronic cigarettes have grown rapidly. The number of
adult smokers who tried e-cigarettes doubled between 2010 and
2011. I am going to focus mostly on the so-called Deeming
Regulation proposed 2 weeks ago by the FDA, but I did want to,
first, read some statistics about the Center for Tobacco
Products.
FDA spent nearly 80 percent of the $1.8 billion in user
fees collected, more than half of the spending, $868 million,
occurred during fiscal year 2013.
FDA has received only four premarket tobacco product
applications, which would have to be filed for any novel
product put on the market after February 2007 if deeming is
finalized as it is. All four were rejected as incomplete. There
are over 4,000 substantial equivalence applications pending for
tobacco products. FDA has decided on 34 of the over 4,500 that
the Agency received. I believe these statistics reflect a poor
performance, and I think it is important to call that to your
attention.
Now, I appreciated being informed about the proposed
regulation. I want to articulate my strong support for the
alternative, exempting premium cigars from FDA regulation. I
have some concerns about that, but I will followup with
questions on how that works. The FDA regulations should fit the
product and risk proposed by that product.
Throughout the proposed regulations, FDA talks about a
somewhat controversial idea of harm reduction. For the 42
million Americans who currently smoke, FDA should enable
companies to find creative ways to reduce the negative health
effects of nicotine addiction, not regulate that innovation out
of existence.
Most of the discussion around the Deeming Regulation in
tobacco seems to be about e-cigarettes, and I am here to
listen. I understand there are competing points of view.
Now, some public health experts, such as David Abrams at
American Legacy Foundation, the largest nonprofit public health
charity in the Nation devoted specifically to tobacco control,
has said, ``This could be the single biggest opportunity that
has come along in a century to make the cigarette obsolete.''
That is one view.
On the other hand, CDC Director, Dr. Frieden, has been
quoted as stating that, ``Many kids are starting out with e-
cigarettes and then going on to smoke conventional
cigarettes.''
So what I would like to understand is what research have we
done to answer those questions. There are reports from
countries overseas that some of these new products do not seem
to be a gateway to traditional cigarette use, but we do not
know that. We do not know that yet.
The purpose of a hearing such as this, and I thank the
chairman for calling this, is not to presuppose an answer, but
to find from experts in our Government what their opinion is.
And what I would like to know is which of those points of view
you subscribe to.
Here is what I think we all have agreement on. The
regulations should be based on data and sound science. No. 2,
no sales to anyone under 18. Any child beginning to use a
tobacco or nicotine product is bad for public health. And No.
3, manufacturers should register and list the products they
make and ingredients they use with the FDA.
After that, I think what we need to focus on is what is the
research and what does it tell us?
I look forward to the testimony. Thank you.
The Chairman. Thank you, Senator Alexander.
I know that Senator Whitehouse has to leave shortly and
maybe Senator Burr; I do not know, but you wanted to make a
short statement. I will recognize Senator Whitehouse.
Statement of Senator Whitehouse
Senator Whitehouse. I appreciate the chairman recognizing
me for 1 minute.
We have two wonderful witnesses here from the FDA and from
the CDC. But I wanted to make the point, as a Senator from
Rhode Island, that there has been some very important corporate
leadership in this area of reducing access to the No. 1 cause
of preventable deaths, which is tobacco. And that comes from
CVS Caremark, a company headquartered in Woonsocket, RI. They
are a very significant pharmacy chain across the country.
Larry Merlo, the CEO, and his management team, has made the
decision to phaseout the sales of tobacco products by October
1st of this year, and I think that is an important and
commendable step. And I just wanted to have that be a part of
the record of this hearing.
The Chairman. Thank you very much, Senator Whitehouse.
Senator Burr.
Statement of Senator Burr
Senator Burr. Mr. Chairman, I never miss an opportunity to
say something when given the opportunity, and since I feel like
I have lived with this issue as long as anybody in Congress,
now 20 years.
And Mr. Zeller, thank you for the job you are doing over
there. A newly created agency. Very, very tough to get up and
run it.
But Mr. Chairman. I can remember when opportunities for
harm reduction were the goal, and it could not be achieved
because the technology did not allow us to get there. I
remember when R.J. Reynolds spent several decades and came out
with a product that, I guess, was a precursor to some degree of
the electronic cigarette, even though it operated differently,
and Mr. Zeller, you might remember that.
And there became a real opportunity for individuals to use
a product that got what they were looking for without a
combustible. And how quickly we have moved to a point where now
harm reduction is no longer a goal and technology now allows us
to get there. It allows us to field products, and trust me, Mr.
Chairman, we can work out these things about flavors and all of
this.
But for God's sakes, let us not say we are not going to let
technology play part of the process of taking more Americans
off of using combustible tobacco products. And I look at the
pool that was available to us when gum came out. We were
ecstatic because this gave the ability for some people to break
the cycle of combustible tobacco products for them.
Then the patch came out. Not everybody could do the gum.
Not everybody can do the patch. And now, we have electronic
cigarettes. Rather than kill this before we know what we have
got, and I am right with the chairman, let us do the science. I
think Mr. Zeller is attempting to do that. I know the job that
is in front. I know the statutory requirements. Let us let him
do it.
But let us not condemn where the technology has gone before
we ever had an opportunity to see, in fact, what effect this
can have on pulling people off of combustible tobacco products.
So I hope the committee and I hope the FDA puts as much
stock in harm reduction in how we get people off of something
that is not as safe to a product that is safer. This is, for
some people, not eliminating access. It is eliminating a
product category. It has been for 20 years and nothing has
changed today, and that is fine.
But as long as I am a member of the committee, Mr.
Chairman, I am going to fight for the American people to have a
right to make a choice, and for Mr. Zeller to determine what
those choices are going to be within reason. And I encourage
you to continue the job you are doing.
I hope that our policies reflect an opportunity for the
American people to make a decision based upon what technology
is available to choose a reduced harm product which, I think,
many of the categories we see today are beginning to move
toward.
I thank the chairman.
The Chairman. Thank you, Senator Burr.
We will start with our first witness, Dr. Tim McAfee. He is
the Director of CDC's Office on Smoking and Health within the
National Center for Chronic Disease Prevention and Health
Promotion. He directs all science, policy, and programming on
tobacco control and prevention.
Dr. McAfee is a family physician who practiced for more
than a decade and served as a clinical faculty member at the
University of Washington Family Medicine and School of Public
Health.
And Dr. McAfee also authored the World Health
Organization's Tobacco Quit-Line Manual for low- and middle-
income countries. Thank you for being here, Dr. McAfee.
And then after Dr. McAfee, we will recognize Mr. Mitch
Zeller, who is the Director of the Center for Tobacco Products
where he leads the FDA's efforts to reduce disease and death
from tobacco use and to develop regulations for a variety of
tobacco products.
Mr. Zeller has been working on FDA issues for more than 30
years. He served as Associate Commissioner and Director of
FDA's first office of Tobacco Programs. And prior to rejoining
the FDA in 2013, Mr. Zeller worked on tobacco control as
executive vice president of the American Legacy Foundation, and
as senior vice president at Pinney Associates. And we thank you
for being here also, Mr. Zeller.
Both of your statements will be made a part of the record
in its entirety. And we would ask if you could just sum it up
in just 5 minutes or so, we would appreciate it, and then we
can get into a discussion.
Dr. McAfee, welcome. Please proceed.
STATEMENT OF TIM McAFEE, M.D., MPH, DIRECTOR, OFFICE ON SMOKING
AND HEALTH, CENTERS FOR DISEASE CONTROL AND PREVENTION,
ATLANTA, GA
Dr. McAfee. Thank you very much, Chairman Harkin and
Ranking Member Alexander, and members of the committee for
their statements previously.
It is an honor to provide this statement to you. I want to
thank Chairman Harkin for his leadership and also recognize
this committee's bipartisan history of support on tobacco
control.
As noted, my name is Dr. Tim McAfee, and I serve as the
Director of the Office on Smoking and Health at the Centers for
Disease Control and Prevention, and I am also a physician.
Today, I will discuss, briefly, the past, present, and
future of tobacco control drawing on findings and
recommendations, primarily from the 50th Anniversary Surgeon
General's Report on Tobacco and Health.
Fifty years ago, half of the men and one-third of the women
in this country smoked cigarettes. Tobacco companies could
advertise everywhere, including TV, and school children carried
lunch boxes with cigarette logos. Smoking was common in public
places.
Today, the landscape is already dramatically different.
Adult cigarette smoking has fallen from 42 percent in 1965 down
to 18 percent today. And tobacco prevention and control
measures saved 8 million lives over the last 50 years.
Today, half of our States prohibit smoking in worksites,
restaurants, and bars. And on TV, we now see the real
consequences of smoking through CDC's Tips from Former Smokers
campaign. These hard-hitting ads show real people fighting
serious disease and disability from smoking. In their first
year, the ads led 1.6 million Americans to make a quit attempt,
and over 100,000 to quit for good.
Now, despite enormous progress, every day, over 3,000
children under age 18 smoke their first cigarette. Smoking-
related deaths approach half a million a year in the United
States, and another 16 million Americans suffer from serious
smoking-related disease.
The 2014 Surgeon General's report concluded that,
``The tobacco epidemic was initiated and has been
sustained by the aggressive strategies of the tobacco
industry, which deliberately misled the public on the
risks of smoking.''
In addition to making their products powerfully addictive,
the tobacco industry spends nearly $1 million an hour on
promotions. They are developing products such as the fruit- and
candy-flavored little cigars and electronic cigarettes. Little
cigars, which are similar in size and shape to cigarettes,
appeal even more to youth than adults because of their flavors
and lower prices.
Responses to our surveys showed cigar use among non-
Hispanic black students in 2012 is nearly double the rate
observed in 2009. And cigarette use among all twelfth graders
surged in recent years to levels that we have not seen in over
a decade.
And e-cigarettes are heavily marketed on TV and radio, and
some marketing includes unproven health claims and themes
proven to appeal to youth. As a result, nearly 1.8 million
students in grade 6 through 12 reported trying an e-cigarette
in 2012.
There are now hundreds of e-cigarette products ranging from
disposables that look like cigarettes to tank devices that are
refillable, adjustable, and they allow for use of other drugs
besides nicotine.
FDA's deeming proposal could establish important regulatory
requirements and allow for more comprehensive protections as we
move forward. However, FDA regulation alone is insufficient and
this process will take time. That is why many States and cities
across the country are folding e-cigarettes into clean indoor
air policies and enacting bans on e-cigarette sales to minors.
Now, what are the many risks with e-cigarettes? The fact
that e-cigarettes exist and are being marketed by some tobacco
companies as being the same as cigarettes, but safer, is a
dramatic shift. According to the Surgeon General's report, e-
cigarettes could be beneficial if they are completely
substituted for burned tobacco and could assist in a rapid
transition to a society with little or no use of burned tobacco
products.
As we consider these issues, we must not forget that burned
tobacco products are overwhelmingly responsible for tobacco-
related death and disease. Yet today, cigarettes remain cheap,
ubiquitous, and heavily marketed. They appeal to children, kill
half of long-time users, and are addictive by design. If
current rates of smoking continue 5.6 million American children
under the age of 18 will die early because of smoking.
Now, the good news is we know a great deal about what works
and we also have a regulatory framework to accelerate our
progress. The bad new is we are not doing enough of what works,
like 100 percent smoke-free policies, higher prices, access to
cessation treatments, hard-hitting media, and State-based
tobacco control programs.
The progress we have made is due to efforts from across our
society including, as noted, from companies like CVS, which
stopped selling tobacco products in October and the thousands
of businesses that are helping their employees quit smoking.
Working together, we can help Americans live longer,
healthier lives. We can prevent 1 in 3 cancer deaths, save our
economy $300 billion annually, and prevent half a million
premature deaths a year.
Thank you for the committee's attention to this important
matter, and I am happy to answer any questions you may have.
[The prepared statement of Dr. McAfee follows:]
Prepared Statement of Tim McAfee, M.D., MPH
summary
Fifty years ago, half of the men and a third of the women in this
country smoked cigarettes. Tobacco companies advertised everywhere and
smoking was common in almost all public places, including hospitals.
Today, however, the landscape is different. Tobacco prevention and
control measures have saved an estimated eight million lives over the
last half-century.* In fact, the success of the tobacco-control
movement constitutes one of the greatest public health achievements of
the 20th century.
---------------------------------------------------------------------------
* Holford TR, Meza R, Warner KE, Meernik C, Jeon J, Moolgavkar SH,
Levy DT. Tobacco control and the reduction in smoking-related premature
deaths in the United States, 1964-2012. JAMA: the Journal of the
American Medical Association 2014.
---------------------------------------------------------------------------
Despite enormous progress, the tobacco epidemic still rages on--in
every community and in every corner of our country. The Surgeon General
has concluded that combusted--or burned--tobacco products, such as
cigarettes, cigars, and pipes, are overwhelmingly responsible for the
burden of death and disease from tobacco use in the United States. And
new, novel tobacco products pose challenges to research, surveillance,
health policy, and regulation because they vary so widely in form, mode
of use, contents, designs and emissions, potential health effects, and
marketing claims.2
---------------------------------------------------------------------------
Consequences of Smoking--50 Years of Progress: A Report of the
Surgeon General. Atlanta (GA), Centers for Disease Control and
Prevention (U.S.).
---------------------------------------------------------------------------
To accelerate declines in tobacco use, the 2014 Surgeon General's
Report emphasizes the effectiveness of comprehensive approaches to
tobacco control that apply a mix of educational, clinical, regulatory,
economic, and social strategies to: prevent initiation of tobacco among
youth and young adults; promote quitting among adults and youth;
eliminate exposure to secondhand smoke, and identify and eliminate
tobacco-related disparities among population groups. While these
evidence-based strategies are currently underutilized, CDC along with
other Federal agencies, States and communities are taking steps to
change that dynamic. Real progress in tobacco control will require
commitment and effort across all sectors of our society including the
business sector.
If we end the tobacco-use epidemic, we can prevent one out of three
cancer deaths in this country and save our economy nearly $300 billion
a year in medical costs and economic losses.
---------------------------------------------------------------------------
U.S. Department of Health and Human Services (2014). Let's Make
the Next Generation Tobacco-Free: Your Guide to the 50th Anniversary
Surgeon General's Report on Smoking and Health. Available at: http://
www.surgeongeneral.gov/library/reports/50-years-of-progress/. Accessed
May 5, 2014.
---------------------------------------------------------------------------
______
Chairman Harkin, Ranking Member Alexander, and members of the
committee, it is an honor to provide this statement for today's hearing
on progress in tobacco prevention and control. Fifty years ago, half of
the men and a third of the women in this country smoked cigarettes.
Tobacco companies advertised everywhere, and school children carried
lunch boxes and wore baseball caps branded with cigarette logos. Except
for churches and grade school classrooms, smoking was common in almost
all public places, including hospitals.
Today the landscape is different. Tobacco prevention and control
measures have saved an estimated eight million lives over the last
half-century.\1\ In fact, the success of the tobacco-control movement
constitutes one of the greatest public health achievements of the 20th
century. Adult smoking rates have fallen from about 43 percent in 1965
to about 18 percent today.\2\ The latest surveys show that cigarette
smoking rates among high school students are at the lowest in our
history of measuring them. Most indoor workplaces are smoke-free and
over half of States prohibit smoking in other indoor areas of public
places such as restaurants, bars, and airports.\2\ Colleges and
universities have embraced these policies, and many have adopted smoke-
free and tobacco-free campuses, indoors and out. Instead of images of
glamorous people enjoying a cigarette, today we see the real health
consequences of smoking through Tips from Former Smokers, the first
federally funded anti-smoking national media campaign in the United
States, which was initially established through the Prevention and
Public Health Fund. These hard-hitting ads pull back the curtain to
reveal real people fighting serious diseases and disabilities because
they smoked, and in their first year led 1.6 million Americans to make
a quit attempt and 100,000 quit for good.\3\
However, we are far from the finish line. Despite enormous
progress, the tobacco epidemic still rages on--in every community and
in every corner of our country. Every day, more than 3,200 children
under age 18 smoke their first cigarette, and another 2,100 youth and
young adults who are occasional smokers become daily smokers.\2\
Smoking-related deaths now approach half a million a year in the United
States, and another 16 million Americans have at least one serious
smoking-related disease.\2\ One-third of all cancer deaths are caused
by smoking, including the vast majority of lung cancers--the leading
cause of cancer death in our Nation for both men and women.\2\
Progress in reducing the disease and death caused by the tobacco
epidemic has not been consistent across all populations. The burden of
smoking now falls disproportionately on some of our most vulnerable
populations--the poor, some racial and ethnic minorities, some members
of the gay and lesbian community, and those living with mental illness
and substance use disorders.\2\
This entirely preventable public health tragedy did not occur by
accident. The Surgeon General concluded that ``the tobacco epidemic was
initiated and has been sustained by the aggressive strategies of the
tobacco industry, which deliberately misled the public on the risks of
smoking cigarettes.'' \2\ Today's cigarettes contain over 7,000
chemicals and chemical compounds--over 70 of which are known to cause
cancer.\4\ They are designed to addict their users quickly and heavily,
speeding a jolt of nicotine to receptors in the brain in as little as
10 seconds after the smoke is inhaled.\5\ The adolescent brain is
especially sensitive to nicotine and teens become dependent on nicotine
more quickly than adults.\6\ In fact, nicotine will cause three out of
four teen smokers to become adult smokers--even though most say they
plan to quit in a few years.\2\ Prevention and intervention in the teen
and youth years is important because nearly 90 percent of adult smokers
say they started before they were 18 years old.\2\
In addition to making their products powerfully addictive, the
tobacco industry spends $8 billion annually--nearly a million dollars
an hour--to advertise and market cigarettes and smokeless tobacco.\2\
They outspend current State tobacco-control programs by a factor of 18-
to-1.\7\ In the United States, the tobacco industry recruits customers
to consume over 14 billion packs of cigarettes a year.\8\ Marketing and
glamorization of tobacco products remains widespread. Despite causal
evidence that depictions of smoking in the movies lead to smoking
initiation among young people, movies remain one of the largest
unrestricted traditional media channels promoting smoking and tobacco
use to youth. In fact, tobacco incidents in PG-13 rated top-grossing
U.S. movies surged 98 percent from 2010 to 2012.\2\
The Surgeon General concluded that combusted--or burned--tobacco
products, such as cigarettes, cigars, and pipes, are overwhelmingly
responsible for the burden of death and disease from tobacco use in the
United States.\2\ Cigarettes carry the highest risk of addiction
following initiation.\2\ This is due to cigarette designs that
facilitate efficient and tolerable inhalation of nicotine-laden toxic
smoke deep into the lung.\2\ In addition to cigarettes, there is an
increasing array of combustible and noncombustible tobacco products on
the market. New, novel tobacco products pose challenges to research,
surveillance, health policy, and regulation because they vary so widely
in form, mode of use, contents, designs and emissions, potential health
effects, and marketing claims.\2\ Combustible product lines include
fruit- and candy-flavored little cigars and cigarillos, which are about
the same size and shape as cigarettes. These are of particular concern
because their flavors and low pricing relative to cigarettes (largely
attributable to differential tax treatment) are appealing to young
people. In fact, research surveys have found that high school boys are
smoking cigars at the same rate as cigarettes.\2\
Noncombustible product lines include smokeless tobacco, dissolvable
tobacco products, and the increasingly prevalent electronic nicotine
delivery systems (ENDS). ENDS, including e-cigarettes, e-hookahs,
hookah pens, vape pens, e-cigars, and others, are battery-powered
devices that provide doses of nicotine and other constituents to the
user in an aerosol. ENDS contain nicotine, which is addictive, toxic to
developing fetuses, and may have lasting consequences for adolescent
brain development.\2\ Potentially harmful constituents also have been
documented in some ENDS, including: irritants, toxicants that can
change genes, and other ingredients that have been shown to cause
cancer in animals.\9\ ENDS are not ``safe,'' and because of the known
risks associated with nicotine, the Surgeon General specifically
cautions against their use by young people and pregnant women.\2\ ENDS
could be less dangerous for the smoker to use than conventional
cigarettes or other combusted tobacco products if and when used by
established adult smokers as a complete substitution for cigarettes\2\
However, the consequences of long-term use of ENDS are unknown.
In 1971, the tobacco companies stopped advertising cigarette and
smokeless tobacco products on television and radio. This had a lasting
impact on deglamorizing smoking.\10\ But now, electronic nicotine
delivery systems are being heavily marketed on television and radio.
The 2014 Surgeon General's Report observed that ENDS marketing ``has
included claims of safety, use for smoking cessation, and statements
that they are exempt from clean air policies that restrict smoking.''
Moreover, some ENDS marketing uses tactics which the Surgeon General
has found lead to youth smoking:\5\ candy-flavored products; youth-
resonant themes such as rebellion, glamour, and sex; and celebrity
endorsements and sports and music sponsorships. This is of concern
because the Surgeon General has found that ``many changes in tobacco
product form and marketing have been documented as efforts by the
tobacco industry to contribute to tobacco use and addiction by
fostering initiation among young people; making products easier and
more acceptable to use; making and marketing products so as to address
health concerns; and making and marketing products to perpetuate
addiction through the use of alternate products, when smoking is not
allowed or is socially unacceptable.'' \2\
These actions appear to be successfully recruiting adult and youth
ENDS users. Results from the HealthStyles survey suggest that adult e-
cigarette experimentation nearly doubled from 2010 (3.3 percent) to
2011 (6.2 percent)\2\ In 2012, approximately 1.8 million students in
grades 6-12 reported ever trying an e-cigarette.\11\ We do not yet know
the long-term health effects that may result from use of ENDS, or the
consequences of exposure to secondhand aerosol for bystanders. The
recent Surgeon General's Report on smoking and health says that ENDS
will cause harm if they:
Encourage nonsmoking youth or adult non-smokers to start
using them and become addicted to nicotine,
Entice former smokers to relapse,
Delay current smokers from trying to break their nicotine
addiction altogether, or
Encourage dual use of combustible tobacco products and
electronic devices.\2\
Additional risks include:
The potential for ENDS to expose bystanders involuntarily
to aerosolized nicotine, and
Accidental poisonings resulting from ingestion or
absorption through the skin of liquids containing high concentrations
of nicotine.
While we respond to the new challenges and opportunities presented
by ENDS, we must remember that cigarettes and other combusted tobacco
products are overwhelmingly responsible for the burden of tobacco-
related death and disease in the United States. Cigarettes remain
cheap; ubiquitous; heavily marketed; appealing to children;
``unreasonably dangerous, killing half of long-term users; and
addictive by design.'' \2\ Every adult who dies prematurely from
smoking in this country is replaced by two younger smokers who have
been recruited to sustain the epidemic.\2\ In fact, if current rates of
smoking by youth and young adults continue, 5.6 million American
children under age 18 will ultimately die early because of smoking.\2\
How do we accelerate the decline in the use of these deadly
products? The good news is that we know a great deal about what works.
The 2014 Surgeon General's Report emphasizes the effectiveness of
comprehensive approaches to tobacco control that apply a mix of
educational, clinical, regulatory, economic, and social strategies to:
(1) prevent initiation of tobacco among youth and young adults,
(2) promote quitting among adults and youth,
(3) eliminate exposure to secondhand smoke, and
(4) identify and eliminate tobacco-related disparities among
population groups.
Unfortunately, the Surgeon General concluded that these evidence-
based strategies are currently underutilized, but we are taking steps
to change that dynamic:
We know that a 10 percent increase in cigarette prices
cuts consumption by 4 percent in adults, and by even more for youth.\6\
Yet many States have excise taxes of less than a dollar on a pack of
cigarettes--and as a result, have higher smoking rates and higher
medical costs to treat smoking-related disease relative to States with
lower excise taxes. The fiscal year 2014 and fiscal year 2015
President's Budgets propose a 94 cent per-pack increase in the Federal
excise tax on cigarettes, which has the potential to prevent at least
450,000 premature deaths of children alive today.
We know that over half of current cigarette smokers want
to quit and at least half will try to quit this year--the Affordable
Care Act expanded access to smoking-cessation services and requires
most insurance companies to cover cessation interventions. Integrating
cessation help into behavioral health treatment will improve cessation
rates, treatment retention, and outcomes for individuals with mental
illness--a group disproportionately affected by tobacco use.
We know that hard-hitting media campaigns such as CDC's
Tips from Former Smokers have the potential to motivate even more
smokers to quit successfully if they are sustained, as the Surgeon
General recommends, at a high frequency for 10 years or more. The
Affordable Care Act's Prevention and Public Health Fund supported the
creation of this innovative campaign, which already has helped tens of
thousands to quit smoking.
We know that smoke-free policies protect nonsmokers from
the dangers of secondhand smoke without harming businesses. Through the
Office of the Assistant Secretary for Health's Tobacco-Free College
Campus Initiative, the number of smoke-free campuses increased 73
percent from 772 in 2012 to 1,343 in 2014. More work remains, as close
to 90 million non-smokers, including over half of children between ages
3 and 11--continue to be exposed to this known carcinogen. This year,
41,000 Americans will die from a disease caused by this exposure.\2\
We know that adequately funded, comprehensive, statewide
tobacco control programs help inform tobacco-free social norms
throughout communities and lower smoking rates and health care costs.
CDC continues to invest in these State-based efforts through the
National Tobacco Control Program. Yet States will spend less than 2
percent of the more than $25 billion they receive in tobacco revenues
this fiscal year on tobacco control.\5\
At the Federal level, the work at the Food and Drug Administration
to implement the landmark Family Smoking Prevention and Tobacco Control
Act of 2009 is critical to further progress, and we are pleased to work
in close partnership with FDA on the work described in its testimony
today. CDC, FDA, and the National Institutes of Health are also
partnering to fill critical research gaps.
We also know that States and cities are taking action--implementing
smoke-free indoor air policies, raising minimum age requirements for
tobacco purchases, and putting policies into place to minimize
potential harms of e-cigarettes. For example:
Over half of States already prohibit e-cigarette sales to
minors, as FDA is proposing in its deeming rule. Some are enforcing
those policies through licensing requirements and penalties for
violations.
Three States prohibiting e-cigarette use in places where
smoking is prohibited such as restaurants, bars, and worksites.
As part of the National Prevention Council, agencies across the
Federal Government are undertaking important commitments to promote
tobacco-free living. For example, the Department of Housing and Urban
Development is increasing access to smoke-free multi-unit housing for
residents.\12\ Within the Department of Defense, efforts are underway
to prevent and reduce tobacco use on DOD installations to promote
health and mission readiness, help tobacco users quit, and lead by
example for all workplaces. In addition, the U.S. Department of
Veterans Affairs health care system provides evidence-based tobacco
cessation counseling and FDA-approved medications for Veterans enrolled
in care, including a national smoking cessation quitline and a mobile
texting program, in collaboration with the National Cancer Institute.
These and other initiatives have extended the reach of tobacco use
treatment to Veterans nationally.
CDC and the Department of Health and Human Services are committed
to providing agencies with technical assistance and support as they
implement these critical, but often challenging commitments. As
resources permit, CDC is also committed to increasing the frequency of
its high-impact Tips from Former Smokers campaign; conducting cutting-
edge research and surveillance to monitor the rapidly changing
landscape of tobacco control; powering comprehensive tobacco control
programs in States, tribes, and territories with resources and
technical assistance, and expanding access to barrier-free tobacco-
cessation treatment, including through 1-800-QUIT-NOW.
Real progress in tobacco control will require commitment and effort
across all sectors of our society--not just local, State, and Federal
agencies. One important partner will be the business community, and we
are seeing some important movement in this sector. A striking example
is the decision by CVS pharmacies to stop selling tobacco products in
all their stores. Employee well-being and productivity also serve as
motivators for business engagement. In addition to providing insurance
coverage for smoking cessation, many large companies offer their
employees free help to quit on the job, with cessation classes and
support groups available throughout the work day. And smoking cessation
as an important part of corporate wellness programs is spreading to
smaller companies as well. Public health and tobacco-control
stakeholders are working together with business leaders around the
country to identify other opportunities for progress.
If we end the tobacco-use epidemic, we can prevent one out of three
cancer deaths in this country.\13\ We can prevent 480,000 premature
deaths a year from smoking-related illnesses.\13\ We can prevent a
third of heart disease cases, 80 percent of chronic obstructive
pulmonary disease cases, and over 90 percent of lung cancer cases.\13\
We can keep 400,000 babies every year from being exposed to the
chemicals in cigarette smoke before they are even born.\13\ We can save
our economy nearly $300 billion a year in medical costs and economic
losses.\13\ And we can help individual men and women live longer,
healthier lives and avoid the pain and suffering that are a part of
preventable diseases caused by smoking.
Thank you.
Endnotes
1. Holford TR, Meza R, Warner KE, Meernik C, Jeon J, Moolgavkar SH,
Levy DT. Tobacco control and the reduction in smoking-related premature
deaths in the United States, 1964-2012. JAMA: the Journal of the
American Medical Association 2014.
2. U.S. Department of Health and Human Services (2014). Reports of
the Surgeon General. The Health Consequences of Smoking--50 Years of
Progress: A Report of the Surgeon General. Atlanta (GA), Centers for
Disease Control and Prevention (US).
3. McAfee, Tim, et al (2013). Effect of the first federally funded
US anti-smoking national media campaign. The Lancet. Published Online
September 9, 2013. Available at: http://dx.doi.org/10.1016/S0140-
6736(13)61686-4. Accessed May 9, 2014.
4. U.S. Department of Health and Human Services. How Tobacco Smoke
Causes Disease--The Biology and Behavioral Basis for Smoking-
Attributable Disease: A Report of the Surgeon General. Atlanta (GA):
U.S. Department of Health and Human Services, Centers for Disease
Control and Prevention, National Center for Chronic Disease Prevention
and Health Promotion, Office on Smoking and Health, 2010.
5. U.S. Department of Health and Human Services. The Health
Consequences of Smoking: Nicotine Addiction. A Report of the Surgeon
General. Atlanta (GA): U.S. Department of Health and Human Services,
Public Health Service, Centers for Disease Control, National Center for
Chronic Disease Prevention and Health Promotion, Office on Smoking and
Health, 1988. DHHS Publication No. (CDC) 88-8406.
6. U.S. Department of Health and Human Services. Preventing Tobacco
Use Among Youth and Young Adults: A Report of the Surgeon General.
Atlanta (GA): U.S. Department of Health and Human Services, Centers for
Disease Control and Prevention, National Center for Chronic Disease
Prevention and Health Promotion, Office on Smoking and Health, 2012.
7. Campaign for Tobacco-Free Kids. Broken Promises to Our Children:
The 1998 State Tobacco Settlement 15 Years Later. Washington: Campaign
for Tobacco Free Kids, American Heart Association, American Cancer
Society, Cancer Action Network, American Lung Association, and Robert
Wood Johnson Foundation, 2013.
8. Maxwell JC. The Maxwell Report: Year End & Fourth Quarter 2011
Sales Estimates for the Cigarette Industry. Richmond (VA): John C.
Maxwell, Jr., 2012
9. Cobb, N. K., M. J. Byron, D. B. Abrams and P. G. Shields (2010).
``Novel nicotine delivery systems and public health: the rise of the
``e-cigarette''.'' Am J Public Health 100(12): 2340-42.
10. Department of Health and Human Services (2000). Reducing
Tobacco Use: A Report of the Surgeon General. Atlanta (GA): U.S.
Department of Health and Human Services, Centers for Disease Control
and Prevention, National Center for Chronic Disease Prevention and
Health Promotion, Office on Smoking and Health, 2000.
11. CDC (2013). ``Notes from the field: electronic cigarette use
among middle and high school students--United States, 2011-12.'' MMWR
Morb Mortal Wkly Rep 62(35): 729-30.
12. Department of Health and Human Services (2010). National
prevention Council Action Plan. Available at: http://
www.surgeongeneral.gov/initiatives/prevention/2012-npc-action-plan.pdf.
Accessed May 5, 2014.
13. U.S. Department of Health and Human Services (2014). Let's Make
the Next Generation Tobacco-Free: Your Guide to the 50th Anniversary
Surgeon General's Report on Smoking and Health. Available at: http://
www.surgeongeneral.gov/library/reports/50-years-of-progress/. Accessed
May 5, 2014.
The Chairman. Thank you very much, Dr. McAfee.
Mr. Zeller, please proceed.
STATEMENT OF MITCH ZELLER, J.D., DIRECTOR, CENTER FOR TOBACCO
PRODUCTS, U.S. FOOD AND DRUG ADMINISTRATION, SILVER SPRING, MD
Mr. Zeller. Thank you, Chairman Harkin, Ranking Member
Alexander, Senator Burr, other members of the committee for the
opportunity to testify today.
I am Mitch Zeller, Director of FDA Center for Tobacco
Products, or CTP as we call it, and I am honored to be here
today to discuss FDA's activities in implementing the Family
Smoking Prevention and Tobacco Control Act since it was signed
into law in June 2009.
Next month, marks the 5-year anniversary of the Tobacco
Control Act, a law that gave FDA comprehensive tools to protect
the public from the harmful effects of tobacco use through
science-based tobacco product regulation.
Since the Act became law in 2009, we have made significant
progress toward establishing a comprehensive, effective, and
sustainable framework for tobacco product regulation.
Our first priority was the creation of the Center for
Tobacco Products, the first new center at FDA in 21 years. CTP
has grown from a handful of employees in the fall of 2009 to
nearly 500 employees today.
During our startup phase, even as the Center was
establishing itself, creating infrastructure, hiring
appropriate personnel, we were required by law to meet more
than 20 mandatory, statutory deadlines. We were also required
to assess user fees, establish the Tobacco Products Scientific
Advisory Committee, known as TPSAC, and refer initially issues
to TPSAC for consideration, and the Center met nearly all of
these many deadlines.
CTP's main responsibilities include reviewing new product
submissions, developing the science base for product
regulation, enforcing the law, issuing regulations and guidance
for industry, and educating the public about the risks
associated with tobacco product use. And I would like to
briefly touch on each of these.
CTP is committed to carefully and thoroughly reviewing all
tobacco product submissions in a consistent, transparent,
predictable, and timely way. And we recently established
performance measures that include timeframes for review of many
of the submissions we receive.
As a regulatory agency, we can only go as far as the
regulatory science will take us. CTP funds and uses scientific
research to better understand tobacco products, how the
differences in products change the behavior of users and
nonusers, and how to best reduce the harm from these products.
We partner with the National Institutes of Health and the
Centers for Disease Control and Prevention, as well as with
FDA's own National Center for Toxicological Research to advance
the regulatory science base.
Vigorous enforcement of the Tobacco Control Act and
implementing regulations is carried out through tobacco retail
compliance check inspections, inspections of domestic
manufacturers and imported tobacco products, and review of
tobacco promotions, advertising, and labeling. CTP also
provides compliance education and training to regulated
industry.
In February, we launched a national public education
campaign called the Real Cost to prevent youth tobacco use and
reduce the number of teens who become regular smokers. The
campaign uses compelling facts and vivid imagery designed to
change beliefs and behaviors over time, to educate youth about
the dangers of tobacco use, and to encourage them to be
tobacco-free.
We have faced some challenges in the 5 years since CTP was
created including the growing pains inherent in building a
regulatory body from the ground up. We have worked through the
logistical challenges of creating a brand new organizational
structure, hiring qualified staff, developing the processes,
procedures, and even the dedicated IT resources to carry out
CTP's important regulatory functions.
Regulating tobacco products is markedly different from
other products traditionally regulated by FDA. Now, our
responsibility is unprecedented. No other country has tasked a
regulatory agency to evaluate new tobacco products before
marketing based on public health criteria. And we have also had
to create a tobacco retail compliance program that is unique
even within FDA.
Moving forward, we intend to sustain the momentum needed to
achieve our goal of reducing the harms and risks associated
with tobacco product use.
I would like to close on a more personal note. After 13
years out of Government, I returned to public service in March
of last year to direct the Center for Tobacco Products. The
main reason I returned to FDA was the public health opportunity
to help use the product regulation tools Congress and the
President granted the Agency in the Tobacco Control Act to help
reduce the death and disease from tobacco use.
The reality is that roughly 1 in 5 adults still smoke, and
we will explore all available regulatory options to reduce the
harm caused by tobacco products.
But perhaps our greatest opportunity to overcome this
pressing public health problem is to dramatically decrease the
access and appeal of tobacco products to youth. We intend to
use the many tools at our disposal to help make the next
generation tobacco-free.
I thank the committee for its efforts and I am pleased to
answer any questions.
Thank you.
[The prepared statement of Mr. Zeller follows:]
Prepared Statement of Mitchell Zeller, J.D.
introduction
Mr. Chairman and members of the committee, I am Mitch Zeller,
director of the Center for Tobacco Products (CTP) at the Food and Drug
Administration (FDA or the Agency), which is part of the Department of
Health and Human Services (HHS). Thank you for the opportunity to be
here today to discuss FDA's activities in implementing the Family
Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control
Act), since it was signed into law on June 22, 2009.
This January we marked 50 years since the first Surgeon General's
Report on Smoking and Health, and how we've learned so much about
tobacco use as the leading cause of preventable disease and death in
this country. We've shifted the perception of smoking from an accepted
national pastime to a discouraged threat to health--and more than
halved smoking rates in this country. This year's Surgeon General's
Report highlighted 50 years of progress in tobacco control and
prevention, presented new data on the health consequences of tobacco
use, and detailed initiatives that can end the tobacco epidemic in the
United States.
But the fact of the matter is, for all the progress we've made over
these past five decades, tobacco-use remains the leading cause of
avoidable death here in the United States and also around the world.
Each year, more than 480,000 Americans lose their lives to tobacco-
related illness. This recent Surgeon General's Report also added new
diseases to the list of those known to be caused by smoking: liver
cancer, colorectal cancer, diabetes, and rheumatoid arthritis, as well
as adding strokes caused by exposure to secondhand smoke. And each day
in the United States, more than 3,200 youth under age 18 try their
first cigarette and more than 700 youth under age 18 become daily
smokers. If we fail to reverse these trends, 5.6 million American
children who are alive today, will die prematurely due to smoking later
in life.
the tobacco control act
In 2009, the Congress passed, and the President signed, the Tobacco
Control Act, which amended the Federal Food, Drug, and Cosmetic Act
(FD&C Act) to authorize FDA to oversee the manufacture, marketing,
distribution, and sale of regulated tobacco products and protect the
public from the harmful effects of tobacco product use. This new
authority gave FDA comprehensive tools to protect the public from the
harmful effects of tobacco use through science-based tobacco product
regulation.
FDA's traditional ``safe and effective'' standard for evaluating
medical products does not apply to tobacco products. With limited
exceptions, FDA evaluates new tobacco products based on a public health
standard that considers the risks and benefits of the tobacco product
to the population as a whole, including users and non-users. Similarly,
when developing regulations, the law generally requires FDA to apply a
public health approach that considers the effect of the regulatory
action on the population as a whole, not just on individual users,
taking into account initiation and cessation of tobacco use.
Under the statute, FDA had immediate authority to regulate
cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless
tobacco. The Tobacco Control Act also authorized FDA to deem other
tobacco products to be subject to the Agency's regulatory authority in
Chapter IX of the FD&C Act. On April 24, 2014, FDA issued a proposed
rule (the ``proposed deeming rule'') to deem additional products that
meet the statutory definition of a ``tobacco product'' (which includes
``any product made or derived from tobacco that is intended for human
consumption'' that is not a drug, device, or combination product under
the FD&C Act) to be subject to FDA's regulatory authority.\1\ Under the
proposed rule, products that would be ``deemed'' to be subject to FDA
regulation, include currently unregulated marketed products, such as
electronic cigarettes (e-cigarettes), cigars, pipe tobacco, nicotine
gels, waterpipe (or hookah) tobacco, and dissolvables not already under
the FDA's authority. Manufacturers of newly deemed tobacco products
would be required, among other things, to:
---------------------------------------------------------------------------
\1\ See FDA, ``News Release: FDA proposes to extend its tobacco
authority to additional tobacco products, including e-cigarettes''
(April 24, 2014), available at http://www.fda.gov/NewsEvents/Newsroom/
PressAnnouncements/ucm394667.htm.
Register their establishments with FDA, report product and
ingredient listings, and report harmful and potentially harmful
constituents;
Market new tobacco products only after FDA review;
Make direct and implied claims of reduced risk only if FDA
confirms that scientific evidence supports the claim and that marketing
the product will promote public health; and
Not distribute free samples.
In addition, under the proposed rule, the following provisions
would apply to newly ``deemed'' tobacco products:
Minimum age and identification restrictions to prevent
sales to underage youth;
Requirements to bear certain health warnings; and
Prohibition of vending machine sales, unless in a facility
that never admits youth.
Issuing the proposed deeming rule was an important step forward in
regulating these products, and finalizing the rule after a thorough
review of comments is a priority for the Agency. Products that are
marketed for therapeutic purposes will continue to be regulated as
medical products under the FDA's existing drug and device authorities
in the FD&C Act.
Between 2008 and 2010, FDA had previously attempted to address
electronic cigarettes (e-cigarettes) as unapproved drug/device
combination products. FDA's action was challenged, and ultimately the
U.S. Court of Appeals for the D.C. Circuit ruled that while FDA could
choose to regulate e-cigarettes and other products ``made or derived
from tobacco'' under its new tobacco authorities, it could not regulate
these products under FDA's drug and device authority. Sottera, Inc. v.
Food and Drug Administration, 627 F.3d 891 (D.C. Cir. 2010). Finalizing
the proposed deeming rule would bring these tobacco products under
FDA's regulatory authority.
FDA welcomes comment on all aspects of the proposed rule. We asked
for comment on a number of specific issues, on which we look forward to
receiving input, research, data and other information from the public
to help inform the development of the Final Rule.
accomplishments since enactment of the tobacco control act
In the nearly 5 years since enactment of the Tobacco Control Act,
FDA has made significant progress toward establishing a comprehensive,
effective, and sustainable framework for tobacco product regulation
that is designed to reduce the impact of tobacco on public health, to
keep people, especially our Nation's youth, from starting to use
tobacco, and to encourage consumers to quit. These major strides
include, among other things:
Establishing an initial framework for industry
registration, product listing, and submission of information on
ingredients and harmful and potentially harmful constituents (HPHCs) in
tobacco products and tobacco smoke;
Requiring cigarette, roll-your-own, and smokeless tobacco
product manufacturers to seek FDA authorization before marketing a new
product or making changes to existing products;
Implementing and enforcing the FD&C Act's prohibition on
the use of marketing terms for regulated tobacco products that imply
reduced risk (such as ``light,'' ``mild,'' or ``low'') without FDA
authorization;
Developing a process for the review and evaluation of
applications for new, modified risk claims, and substantially
equivalent (SE) tobacco products;
Implementing and enforcing the statutory ban on cigarettes
with certain characterizing flavors;
Increasing regulatory science capabilities through
research to better understand regulated products and patterns of
tobacco use;
Restricting access and marketing of cigarettes and
smokeless tobacco products to youth;
Implementing a compliance and enforcement program to
ensure industry compliance with regulatory requirements; and
Establishing public education campaigns about the dangers
of regulated tobacco products.
These accomplishments demonstrate FDA's commitment to effectively
regulate the manufacture, marketing, and distribution of tobacco
products and to advance tobacco product regulations appropriate for the
protection of public health.
establishing the center for tobacco products
FDA's first priority following the enactment of the Tobacco Control
Act was creating the Center for Tobacco Products (CTP or the Center),
FDA's first new center in 21 years. CTP oversees the implementation of
the FDA tobacco program, and has been tasked with developing the
scientific, regulatory, and public education infrastructure necessary
to implement and track FDA's goals for meaningful product regulation
that will help reduce the harms associated with tobacco products and
prevent initiation of tobacco use (particularly among youth).
From a handful of employees in the fall of 2009, the Center has
grown to nearly 500 employees, including regulatory counsels, policy
analysts, scientists, researchers, management officers, communications
specialists, and other professionals who are designing and implementing
a comprehensive program of tobacco product regulation. Key objectives
involved in launching CTP have included recruiting management officials
to lead the Center, hiring skilled staff, setting up necessary
infrastructure and technology resources, and putting in place processes
to meet statutory deadlines and directives.
During its startup phase, FDA quickly established the foundation
for meeting the many mandatory statutory deadlines included in the
Tobacco Control Act. The law contains more than 20 statutory deadlines
by which FDA was required to issue certain regulations, guidance
documents, Reports to Congress, and a list of harmful and potentially
harmful constituents, among other things. Most of these deadlines were
in the first 3 years after the law went into effect. Therefore, even as
the Center was establishing itself, creating infrastructure, and hiring
appropriate personnel, it was required to develop a significant number
of regulations and guidance documents on precedent-setting, complex
issues. In addition, the Center was required to assess user fees,
establish the Tobacco Products Scientific Advisory Committee (TPSAC),
and refer to TPSAC the issue of the impact of the use of menthol in
cigarettes on the public health, within its first year. The Center met
nearly all of the more than 20 statutory deadlines.
CTP undertakes four broad categories of activities in carrying out
its responsibilities and authorities under the Tobacco Control Act:
reviewing submissions for marketing new tobacco products
and developing the science base for product regulation;
enforcing statutory and regulatory requirements to ensure
regulated industry and tobacco products are in compliance with the law;
developing and issuing regulations and guidance for
industry; and
engaging in public education and outreach activities about
the risks associated with tobacco product use, and promoting awareness
of and compliance with the Tobacco Control Act.
I will briefly describe some of CTP's accomplishments in each of
these areas over the last 5 years, as well as note some of the
challenges that we have faced in carrying out our responsibilities and
authorities under the Tobacco Control Act.
the tobacco product review process
The Tobacco Control Act requires manufacturers to seek FDA
authorization before marketing a new tobacco product, including when
modifying an existing product; the FD&C Act defines a ``new'' tobacco
product as a product not commercially marketed in the United States as
of February 15, 2007, or a product already on the market that is
modified after that date. Products that were on the market on February
15, 2007, and which have not been modified, can continue to be marketed
without FDA authorization. This review process gives FDA the ability to
help ensure that the marketing of any new product, including a modified
product, is appropriate for the protection of public health and allows
for greater awareness and understanding of the changes being made to
tobacco products. There are three ways a new tobacco product, including
an existing product that is modified, can obtain FDA authorization for
distribution or retail sale: a premarket tobacco product application;
an application demonstrating substantial equivalence (SE) to certain
commercially marketed products; or an application for exemption from
demonstrating SE.
Premarket tobacco product applications: One pathway for a
new tobacco product to receive market authorization is through the
Premarket Tobacco Product Application (PMTA) process.\2\
---------------------------------------------------------------------------
\2\ In September 2011, FDA issued a draft guidance document
describing what the FD&C Act requires to be submitted in a new tobacco
product application. The draft guidance also sought comment on the
information to be included in the application that the agency would use
to determine whether the marketing of a new tobacco product is
appropriate for the protection of the public health, as determined with
respect to the risks and benefits to the population as a whole,
including users and non-users of tobacco products, and taking into
account the impact on cessation and initiation.
---------------------------------------------------------------------------
Demonstrating substantial equivalence to certain
commercially marketed products: Demonstrating SE to a product already
on the market is a second pathway to marketing authorization under
specific circumstances. Under the SE pathway, whenever an existing
tobacco product is modified, the manufacturer must submit a report with
sufficient scientific data and information to FDA to demonstrate either
that the product characteristics, as compared to the predicate product,
are the same or that the tobacco product has different characteristics
but does not raise different questions of public health.\3\ This means
that products brought to market through this pathway should not present
more harm to public health than a valid predicate tobacco product.
---------------------------------------------------------------------------
\3\ Products that were first introduced or delivered for
introduction into interstate commerce for commercial distribution
between February 15, 2007, and March 22, 2011, and for which SE reports
were submitted prior to March 23, 2011, can remain on the market unless
FDA issues an order that they are ``not substantially equivalent
(NSE).'' FDA refers to these SE reports as ``provisional.'' An SE
report for a tobacco product submitted after March 22, 2011 is
considered a ``regular'' report and the product covered by the
application cannot be marketed unless FDA first issues an order finding
the product substantially equivalent and in compliance with the FD&C
Act. FDA issued a guidance document in January 2011 describing the
content and data to be included in the report and the process for its
review.
---------------------------------------------------------------------------
Exemption from demonstrating substantial equivalence: The
third pathway for new tobacco products is a request for an exemption
from the SE requirements. This pathway is available for products
modified by the addition or deletion of an additive or a change in the
quantity of an existing additive, if FDA finds the modification of the
product to be minor; FDA determines an SE report is not necessary to
ensure that permitting the tobacco product to be marketed would be
appropriate for the protection of public health; and an exemption is
otherwise appropriate.\4\
---------------------------------------------------------------------------
\4\ In July 2011, FDA issued a final rule on ``Exemptions from
Substantial Equivalence Requirements'' that established the procedures
for requesting an SE exemption.
---------------------------------------------------------------------------
In addition to creating the pathways for marketing of new tobacco
products, the statute directs FDA to evaluate and authorize marketing
of modified risk tobacco products (MRTPs). MRTPs are tobacco products
sold or distributed for use to reduce harm or the risk of tobacco-
related disease. These include products whose labeling or advertising
represents (explicitly or implicitly) that the product is less harmful
or presents a lower risk of tobacco-related disease than commercially
marketed tobacco products, or that the product or its smoke contains a
reduced level of, presents a reduced exposure to, or does not contain
or is free of a substance.
In order for a tobacco product to make claims that the product
``presents a lower risk of disease,'' an applicant must show that the
product will significantly reduce harm and the risk of tobacco-related
disease to individual tobacco users and benefit the health of the
population as a whole, taking into account both users and non-users of
tobacco products.
There is also a ``Special Rule'' for certain MRTPs, such as those
that claim to ``present a reduced exposure to a substance.'' FDA may
issue an order for such products if, among other things, the order
would be appropriate to promote the public health; the claims for the
product are limited to claims that the product does not contain or is
free of a substance, contains a reduced level of a substance, or
presents a reduced exposure to a substance; scientific evidence to
satisfy the lower disease risk standards cannot be made available
without conducting long-term epidemiological studies; and the available
scientific evidence demonstrates that a measurable and substantial
reduction in morbidity/mortality among individual users is reasonably
likely in subsequent studies.
FDA review of a new product, including a modified product, requires
scientific and technical expertise in order to assess how the product
design, ingredients, and other characteristics impact the public
health.
Substantial equivalence is one pathway manufacturers can use to
seek permission to market a new tobacco product. The primary pathway,
however, is through the filing of a new tobacco product application. As
of May 1, 2014, FDA had not received any complete premarket
applications for new tobacco products for which we can commence a
scientific review.
As of May 1, 2014, FDA had received a total of 4,580 submissions
seeking to demonstrate SE to a predicate product, including 3,578
``provisional'' submissions that were received before March 23, 2011,
and apply SE to products currently marketed in the United States. The
remaining 1,002 applications are ``regular'' submissions for products
not currently on the market.
FDA is committed to carefully and thoroughly reviewing all
submissions in order to protect the public health as required by the
FD&C Act. FDA is also committed to a consistent, transparent, and
predictable review process and to completing reviews of all new product
applications in a timely manner.
CTP has prioritized the review of regular SE submissions and has
made progress in each of the three key steps in the SE review process:
(1) jurisdiction review; (2) administrative review; and (3) scientific
review. As of May 1, 2014, CTP has completed the jurisdiction review of
4,559 SE submissions and completed administrative review of 4,384 SE
submissions and provided acknowledgment and, where appropriate,
administrative advice and information letters to the applicants seeking
information required for review. On March 24, 2014, CTP announced that
we no longer have a backlog of regular SE reports awaiting review. CTP
is starting review on regular SE reports as they are received. As of
May 12, 2014, 257, or 25 percent of regular SE submissions have been
resolved, either because CTP issued a determination (34 submissions) or
because the submission was withdrawn (223 submissions). Fifty-seven
percent of the Regular SE Report withdrawals reported to FDA were
withdrawn after CTP issued an action letter which identified
deficiencies in the submission.
CTP has completed an initial evaluation of the 3,559 provisional SE
reports to guide the order of review so that those products that remain
on the market and present the highest likelihood of raising a different
question of public health will be reviewed first. CTP has begun review
of provisional SE reports and issued the first decisions on these
reports on February 21, 2014. These decisions marked the first time
that FDA used its authority under the Tobacco Control Act to order a
manufacturer of currently available tobacco products to stop selling
and distributing them.\5\ The products were found to be not
substantially equivalent to predicate tobacco products, therefore under
the Tobacco Control Act, they can no longer be sold or distributed in
interstate commerce or imported into the United States.
---------------------------------------------------------------------------
\5\ http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/
ucm386707.htm.
---------------------------------------------------------------------------
FDA has received 59 requests to consider certain products to be
exempt from the SE requirements. To be considered for an exemption,
requests must meet the requirements in the statute and regulations. CTP
published a final regulation on the SE exemption pathway on July 5,
2011. FDA has refused to accept 35 requests for SE exemption because
they did not meet the statutory and regulatory requirements. The
remaining 24 requests are under administrative, eligibility, or
scientific review.
There are many factors that can affect the timing of a
determination by FDA, including the completeness of an application or
whether there is a need for manufacturers to submit more information or
provide an additional explanation so that FDA can complete its
assessment. It is important to note that there was a wide range of
quality in SE reports submitted thus far by the tobacco industry. In
almost all cases, reports that have been submitted lack both
information referenced in FDA guidance documents to facilitate FDA
review and information required by statute for FDA to make its
determination. Examples of some of the general issues that FDA is
observing across multiple applicants include:
Reports containing contradictory statements, particularly
about whether the product characteristics were the same or different;
Reports identifying a predicate product that does not meet
the statutory requirement;
Reports lacking information to completely understand
product composition, including information about the tobacco blend used
in the product;
Reports missing specifications on components used in the
manufacture of the finished product;
Reports with HPHC measurements that were scientifically
inadequate or did not include information needed to evaluate data
quality; and
Reports in which information on product design was
incomplete, preventing a scientific assessment.
In response to industry feedback, where possible, FDA has been
taking steps that would streamline the SE review process, by:
increasing opportunities for communication with industry
by encouraging teleconferences between the assigned FDA regulatory
project manager and the submitter;
taking steps to facilitate quicker responses to questions;
modifying the initial review for completeness to focus
only on administrative issues, so that applicants can be notified more
quickly about submission deficiencies;
hosting webinars for tobacco manufacturers specifically to
discuss the types of information that the Agency needs to complete the
review of SE reports;
issuing a September 2011 draft guidance document for
public comment with responses to frequently asked questions about
demonstrating SE of a new tobacco product; and
launching a new section on the Agency's Web site,
providing comprehensive information on the pathways available to
legally market new tobacco products, including SE.
In addition to streamlining the SE review process, FDA is taking
other steps to improve the timeliness of product reviews. In fiscal
year 2013, CTP increased the number of scientific staff by 38 percent,
mostly to perform reviews. CTP plans to continue to hire many more
scientists and expects the time required for review of SE submissions
to get substantially shorter as CTP continues to improve the efficiency
of its review process and as the quality of reports received from
industry improves.
In addition to hiring more scientific staff to perform reviews,
last month, the Center established four performance measures that
include timeframes for review of regular SE Reports, review of
Exemption from SE Requests, review of MRTP Applications, and for
responding to meeting requests. Beginning on October 1, 2014, all four
measures will be implemented. The interim time between now and October
1, 2014, will be used to develop tracking systems for monitoring
progress in meeting the performance goals. As FDA gains more experience
with reviewing provisional SE Reports, we intend to identify and
implement performance standards for these submissions as well.
tobacco regulatory science
CTP relies on the most current science to make regulatory decisions
on tobacco products. The Center funds and uses scientific research to
better understand tobacco products, how the differences in products
change the behavior of users and non-users, how they cause death and
disease, and how to best reduce the harm from these products.
CTP has identified seven categories of research priorities:
Product diversity--understanding the types of tobacco
products and how their specific characteristics affect people's use of
these products, as well as their attitudes, beliefs, and perceptions
about these products.
Addiction--understanding what effect different levels of
nicotine and other factors have on addiction.
Toxicity and carcinogenicity--understanding how changes in
tobacco products affect their potential for harm and ways to reduce
that harm.
Health consequences--understanding the risks of different
tobacco products.
Communication--finding ways to effectively convey
information about the risks of using tobacco and about CTP's role in
regulating tobacco products.
Marketing--understanding the impact of tobacco product
marketing and public education on people's attitudes, beliefs,
perceptions, and use.
Economics and policy--estimating the economic impact of
CTP's regulations; also understanding how CTP's actions change tobacco
use and illness and death from tobacco use.
CTP partners with other agencies, such as the National Institutes
of Health (NIH) and Centers for Disease Control and Prevention (CDC),
as well as with FDA's National Center for Toxicological Research, to
continue to advance the regulatory science base. For example, CTP is
partnering with NIH to support important research efforts, including:
The Population Assessment of Tobacco and Health (PATH)
Study: The PATH Study will help scientists learn how and why people
start using tobacco, switch products, quit using tobacco, and start
using it again after they've quit. By monitoring and assessing the
behavioral and adverse health impacts of tobacco use in the United
States, the PATH Study will add to the evidence base to inform
regulatory decisions about the marketing, manufacture, and distribution
of tobacco products. Because this is a longitudinal study following the
same individuals, with appropriate consent, over years, FDA will be
able to draw scientific conclusions on how users transition from the
use of one product to another and from experimentation to regular use
and how these choices impact the ultimate death and disease resulting
from their use. The PATH survey went into the field in September 2013,
the data will be available in the fall of 2015 for researchers by
request, and the publicly available baseline survey dataset is expected
in spring 2016. Any publicly released data will protect the identity of
the participants.
Tobacco Centers of Regulatory Science (TCORS): TCORS is a
new research program designed to generate research to inform the
regulation of tobacco products to protect public health. The program
was initially funded in 2013 and will run up to 5 years. Essential
elements of these centers include an overall focus on the high-priority
tobacco regulatory program needs for CTP; three or more theoretically
grounded, strong research projects with an integrative theme; the
ability to respond quickly to emerging research questions through pilot
projects; and a program for career development to train future
generations of researchers in tobacco regulatory science.
In addition, in response to the Court of Appeals decision on FDA's
rule requiring that all cigarette packages bear one of nine new textual
warnings and include color graphics depicting the negative health
consequences of smoking, FDA is undertaking research to support a new
rulemaking consistent with the Tobacco Control Act and actively working
to move forward on this important issue.
compliance and enforcement activities
Vigorous enforcement of the Tobacco Control Act and implementing
regulations is carried out through tobacco retail compliance check
inspections, inspections of domestic manufacturers and imported tobacco
products, and surveillance and review of tobacco promotions,
advertising, and labeling. CTP also provides compliance education and
training to regulated industry.
The FD&C Act instructs FDA to contract, where feasible, with the
States, to carry out inspections of retailers in connection with the
enforcement of the Tobacco Control Act; the retail inspection program
provides a framework for a nationwide FDA enforcement strategy through
the credentialing of more than 1,100 State and territorial officials
and a comprehensive training program for these FDA-commissioned
inspectors and program coordinators. CTP has awarded contracts for
tobacco retail inspections in 48 States and territories, with awards
totaling more than $93 million since the program began. Measurable
accomplishments in the retail inspection program from 2009 through May
1, 2014, include:
Conducting more than 289,000 compliance check inspections
of regulated tobacco retailers utilizing State and territorial
contractors;
Issuing over 14,800 warning letters to retail
establishments where violations were found during compliance check
inspections;
Issuing over 1,430 CMP administrative actions to retail
establishments where subsequent violations were found during followup
compliance check inspections; and
Developing an online searchable data base of retail
compliance check inspection results.\6\
---------------------------------------------------------------------------
\6\ See FDA, ``Compliance Check Inspections of Tobacco Product
Retailers,'' available at http://www.accessdata.fda.gov/scripts/oce/
inspections/oce_insp_searching.cfm.
Active and effective enforcement of tobacco laws and regulations
governing the promotion, advertising, and labeling of tobacco products
can help to protect the public health by preventing the sale and
distribution of misbranded and adulterated tobacco products, including
those with marketing and advertising materials that violate the
requirements of the Tobacco Control Act. In this regard, FDA reviews
and evaluates regulatory submissions that include tobacco product
labeling, representative advertising, and consumer information
materials; conducts routine monitoring of Web sites and publications
that sell, distribute, promote, or advertise regulated tobacco
products; and conducts surveillance of event promotion and sponsorship
by tobacco manufacturers, distributors, or retailers.
CTP has issued a number of letters to manufacturers requesting
information regarding their marketing and advertising practices. For
example, FDA has requested information on events that include the
distribution of free samples of smokeless tobacco products, internet
marketing activities, and other relevant information to determine
compliance. From 2009 through May 1, 2014, FDA's promotion,
advertising, and labeling compliance and enforcement program has:
Monitored approximately 3,000 Web sites and more than
74,000 publication issues where regulated tobacco products might be
sold, distributed or advertised.
Issued over 150 Warning Letters as a result of CTP's
monitoring and surveillance of tobacco advertising, labeling, and other
promotional activities; and
Reviewed 38 smokeless tobacco warning plans and 13
smokeless tobacco warning plan supplements.
FDA conducts biennial inspections of registered tobacco product
establishments that manufacture regulated tobacco products in the U.S.
market. These inspections are designed to determine compliance with
requirements of the FD&C Act, including establishment registration,
product and ingredient listing, packaging, labeling, and advertising
requirements, and marketing authorization for new or modified risk
tobacco products. In the area of manufacturing compliance and
enforcement, through May 1, 2014, FDA has:
Conducted more than 120 inspections of registered tobacco
product facilities;
Conducted more than 20 investigations that included
sponsorship events and distribution of free sample events; and
Reviewed over 77,500 lines of imported tobacco products,
completing over 1,100 field exams and more than 1,900 label exams, and
refusing more than 70 entries, in collaboration with U.S. Customs and
Border Patrol (CBP). We have also issued four import alerts that
directed many of these reviews and exams.
CTP also provides compliance education and training to regulated
industry to ensure that those who must understand the law and
regulations have the resources to do so. In 2011, FDA started hosting
live webinars to help educate regulated industry and encourage
compliance with Federal tobacco laws and regulations. Public webinars
allow retailers and small businesses to watch and ask live questions.
Each webinar addresses a specific subject, including published
guidance, and many of the webinars are archived on the Center's Web
site for future viewing. Industry can also suggest topics for future
webinars.
In addition, one of FDA's initial activities was to establish the
Office of Small Business Assistance within CTP to assist small tobacco
product manufacturers and retailers in complying with the Tobacco
Control Act. The office has a dedicated Web page, e-mail address, and
staff to assist small businesses with their questions, comments, and
concerns.
``the real cost'' and other public education campaigns
The Tobacco Control Act gives FDA the authority to educate the
public about the dangers of regulated tobacco product use. To advance
efforts to protect the public from the harmful effects of tobacco use,
FDA is developing integrated, far-reaching, and evidence-based public
education campaigns related to FDA's regulatory activities, including
informing consumers about risks from tobacco use and preventing youth
tobacco initiation, and promoting tobacco use cessation among youth.
FDA has awarded multiple contracts for public education campaigns
to conduct sustained, multi-media efforts that will enable FDA to
educate the public, and vulnerable youth populations in particular,
about the harms and risks of regulated tobacco products in order to
help prevent youth initiation and encourage cessation. Specifically,
these campaigns will equip the public with important facts about the
health risks and addictiveness of regulated tobacco products and the
HPHCs in regulated tobacco products.
In February, we launched a national public education campaign to
prevent youth tobacco use and reduce the number of kids ages 12 to 17
who become regular smokers. ``The Real Cost'' campaign is the first of
several planned tobacco education campaigns;\7\ it targets the 10
million young people ages 12-17 who have never smoked a cigarette but
are open to it as well as youth who are already experimenting with
cigarettes and are at risk of escalating their use. ``The Real Cost''
campaign uses a comprehensive multimedia approach with compelling facts
and vivid imagery designed to change beliefs and behaviors over
time,\8\ educate youth about the dangers of tobacco use and to
encourage them to be tobacco-free.\9\ Supported by the best available
science, ``The Real Cost'' campaign will be evaluated to measure its
effectiveness over time.
---------------------------------------------------------------------------
\7\ Was not supplied.
\8\ Was not supplied.
\9\ See http://www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/AbouttheCenterforTobaccoProducts/
PublicEducationCampaigns/TheRealCostCampaign/ucm384
305.htm.
---------------------------------------------------------------------------
In addition, FDA is overseeing a variety of research and analytic
activities to strengthen and inform public education initiatives and
efforts. This includes awarding a contract to conduct rigorous outcome
evaluations on the effectiveness of individual FDA tobacco-related
public education campaigns, overall messaging, and related
communications activities. This combination of establishing and
evaluating evidence-based public education campaigns will enable the
Agency to implement effective models for educating the public about the
risks and dangers of regulated products, and will also complement
public education initiatives by our partner agencies, including CDC, on
tobacco-related issues.
addressing challenges and advancing the tobacco control act
Some of the challenges that we have faced in these early years are
the growing pains inherent in building a regulatory body from the
ground up. FDA has worked through the logistical challenges of creating
a new organizational structure, recruiting and hiring qualified staff
with applicable experience in a short timeframe, and developing the
processes, procedures and dedicated information technology resources to
carry out CTP's important regulatory functions.
There are challenges intrinsic to the regulation of tobacco
products, which are markedly different from other products
traditionally regulated by FDA. For example, FDA has created and
validated entirely new scientific testing procedures for the
measurement of HPHCs in tobacco products and tobacco smoke, and
developed metrics for the evaluation of product applications, including
the SE applications now under review. The responsibility given to FDA's
Center for Tobacco Products for the premarket public health review of
tobacco product applications and reports is unprecedented. No other
country's regulatory agency has been given the responsibility to
evaluate new tobacco products before they are marketed and determine
which products will be authorized for marketing based on public health
criteria. FDA also established and implemented a tobacco retail
compliance program that is unique even within the Agency. Tobacco
product regulation also involves the regulation of an industry that is
new to Federal product regulation and often unfamiliar with and
continuing to learn what is expected in the regulatory process.
conclusion
Moving forward, FDA will sustain the momentum needed to achieve its
goals for reducing the harms and risks associated with tobacco product
use. Despite the common misperception that decades of program and
policy efforts have solved this problem, the reality is that tobacco
use continues to be the leading cause of preventable death and disease
in the United States. The total economic burden of cigarette smoking is
estimated to be nearly $300 billion in annual health care and
productivity costs. FDA will work to finalize the proposed deeming rule
in a timely manner; expand the tobacco regulatory science base;
continue to improve product review processes to enable the Center to
make timely decisions; expand the compliance program to conduct
enforcement in additional States; and develop and implement additional
public education campaigns.
In addition to the activities described above, FDA plans to explore
the potential for tobacco product standards and is investing in
research to support potential product standards to reduce product
addictiveness, toxicity, and/or appeal.
Roughly one in five adults still smoke. Those numbers are even
higher in States like Kentucky and West Virginia, where smoking rates
greatly exceed the national average.\10\ FDA cares greatly about the 43
million addicted smokers, and one of our core goals is to reduce the
harmfulness of tobacco products. We will explore all available
regulatory science to do that.
---------------------------------------------------------------------------
\10\ See CDC, ``Behavioral Risk Factor Surveillance System,'' at
http://apps.nccd.cdc.gov/brfss/
list.asp?cat=TU&yr=2012&qkey=8161&state=All.
---------------------------------------------------------------------------
Perhaps the greatest opportunity FDA has to overcome this pressing
public health problem is to dramatically decrease the access and appeal
of tobacco products to youth. Ninety percent of smokers start smoking
by age 18, and 99 percent start by age 26; and despite years of steady
progress, declines in the use of tobacco by youth and young adults have
slowed for cigarette smoking and stalled for smokeless tobacco use.\11\
FDA intends to use the many tools at its disposal to continue the
decline in tobacco use and to reinvigorate public determination to
arrest the epidemic by making the next generation tobacco-free. The
Agency remains committed to making tobacco-related death and disease
part of America's past, not its future.
---------------------------------------------------------------------------
\11\ U.S. Surgeon General, ``Preventing Tobacco Use Among Youth and
Young Adults: A Report of the Surgeon General'' (2012), available at
http://www.surgeongeneral.gov/library/reports/preventing-youth-tobacco-
use/exec-summary.pdf.
---------------------------------------------------------------------------
Thank you for the opportunity to testify today about FDA's
accomplishments and challenges in the 5 years since enactment of the
Tobacco Control Act. I am happy to answer questions you may have.
The Chairman. Thank you very much, Mr. Zeller.
Now, we will open rounds of 5 minute questions.
Dr. McAfee, I will start with you. We both already
mentioned the hard-hitting and incredibly effective Tips from a
Former Smoker campaign created using resources from the
Affordable Care Act's Prevention and Public Health Fund; I
mentioned that in my statement.
The outcomes of this campaign, at least what I have seen,
have been extraordinary. You mentioned more calls to the quit
lines. I think you said 1.6 million calls. More quit attempts
mean ultimately more long-term quitters.
Can you, again, just elaborate on CDC's work on this
campaign? How did they decide on messages? What evidence do you
have that your message is effective? And then last, is there a
difference between the CDC media campaign, Tips from a Former
Smoker, and FDA's media campaign, the Real Cost?
Dr. McAfee. Thank you very much, and please feel free to,
if I do not remember each one of the ones that you asked about,
to refresh my memory.
As you noted, Chairman Harkin, the campaign has been
remarkably successful. The 1.6 million figure was actually the
number of people who made a quit attempt because of the
campaign just in the first year of the campaign. We also saw
concurrently, we are now in our third year now, and we have
also seen doublings in calls to the national 1-800-QUIT-NOW
telephone number. And as much as fivefold increases in visits
to the website of the campaign. So we are very excited by this.
We are particularly excited about the very specific information
about quit attempts that we saw with the campaign.
We also saw increases in nonsmokers, millions of whom said
that they had actually talked to a loved one who smoked and
encouraged them to get help quitting.
I think one of the reasons, however, that we were not
surprised by these results is that we put a lot of work in up
front. First, reviewing all the information from other
countries' and other States' experiences that had done
campaigns.
And then working with literally thousands of smokers asking
them, ``What would be most helpful to you to make a quit
attempt a successful quit attempt?'' And we designed the
campaign through several cycles of trying out our ideas and
then checking back with smokers to see what they said. And they
were very firm that this was the type of campaign that they
wanted.
We have also seen, 80 to 90 percent of smokers say that
they have seen the ads. So we are feeling very, very strong
about the response that we have had. I would just also mention
that Terrie Hall from North Carolina, who died in September at
53, was our real poster child. Of the 30 people, Americans,
that stepped up, very difficult step to show, to put a face on
what the harms of smoking will cause.
In terms of your question about FDA and CDC.
The Chairman. Yes, the two different approaches.
Dr. McAfee. Yes. We are really in different swim lanes
because the CDC program is focusing on adult smokers and
encouraging them to quit. That is its laser focus. And the
FDA's campaign, which Mr. Zeller can talk more about, but we
are actually quite excited about the work that they have been
doing, is also laser focused on youth in initiation and trying
to keep experimenters from consolidating. So we are doing very
different things.
And the other thing to keep in mind is both campaigns
combined represent, in terms of the amount of promotional
effort that we are able to make, represents about 5 days out of
a year of what the tobacco companies are spending, $8.5
billion.
The Chairman. You are talking about both combined?
Dr. McAfee. Yes, both ours combined, both the FDA and CDC's
campaign. Ours is----
The Chairman. About 5 days out of----
Dr. McAfee. Three hundred and sixty-five.
The Chairman. Three hundred and sixty-five that would be
funded by the tobacco companies.
Dr. McAfee. Right.
The Chairman. Mr. Zeller, in my brief time, again, just
elaborate a little bit on the Real Cost.
Mr. Zeller. Sure. Unfortunately, too many kids experiment
with cigarettes each day for the first time, over 3,000 and
over 700----
The Chairman. A day?
Mr. Zeller. Each day and each day, over 700 kids make the
progression from experimentation to becoming regular smokers.
The good news is compared to 20 years ago, those numbers
are down. The bad news is those numbers are still
unconscionably high from a public health perspective.
There are 25 million 12- to 17-year-olds in our entire
country and from the research that we did and we spent 2 years
doing research before we launched the Real Cost campaign in
February.
What we came to understand is that there is about 10
million of those 25 million teens who are at-risk. We call them
being, literally, one party away from taking that first puff or
they have already started to smoke a few cigarettes, and they
are on that trajectory to becoming regular smokers. And from
our research, we developed insights into how to communicate to
these kids in ways that will breakthrough.
The initial launch of the campaign is focused on the health
consequences of smoking and addiction, but we do not talk to
them like an adult lecturing a child about, ``Do not smoke and
here are the long term risks.''
It turns out that if you talk to at-risk kids about
premature skin wrinkling or gum disease and tooth loss. And
if--instead of talking to them about nicotine and addiction--
you talk to them about loss of control if they become addicted
to cigarettes, that enables them to hit the pause button; that
enables them to rethink their relationship with the cigarette.
We also made a major investment in evaluation, so we will see
how we are doing over time.
It starts with building awareness. That will lead to
changes in attitudes and belief, and then ultimately changes in
behavioral intent and behavior. And we have made the investment
in the evaluation to follow 8,000 of our target over the next
couple of years to see how we are doing.
The Chairman. Very good. Thank you both very much.
Senator Alexander.
Senator Alexander. Mr. Zeller, on one point, I think you
are correct that premium cigars should be treated differently.
I support the option and the regulation that would exempt
premium cigars from FDA regulation. I introduced legislation
like that some time ago. I believe people ought--adults--ought
to be able to make their own choices.
And I had a couple of questions, how would this price of
$10 at retail work? What if one retailer sold a cigar at $9.99?
What would that do?
Mr. Zeller. Let me just clarify one thing, Senator. We have
proposed regulatory options on cigars.
Senator Alexander. Yes.
Mr. Zeller. And one of the options is to exempt premium
cigars.
Senator Alexander. Right.
Mr. Zeller. The other is to include them, and we are in a
rulemaking period now, and we need to wait for all the comments
to come in, and we will then consider our regulatory options,
in large part, informed by the information that comes in.
Senator Alexander. But you cannot comment on how it would
work?
Mr. Zeller. No. I just want to say, I do not want to
prejudge what the outcome of the rulemaking would be.
Senator Alexander. No, I was trying to prejudge it a little
bit.
Mr. Zeller. Which are free to do and I am not.
Senator Alexander. Right. I understand.
Mr. Zeller. But to your question about the price point, in
the option that we laid out where premium cigars would be
exempted, there would have to be a definition of premium
cigars.
Senator Alexander. Right.
Mr. Zeller. So that we would know what is in.
Senator Alexander. And if the price point seems to be, that
might not work very well.
Mr. Zeller. We have asked for comment on every aspect of
the definition including the price point. And if people have a
better way of us doing the price point than what we propose,
which is $10 per cigar, we welcome information on the record.
Absolutely.
Senator Alexander. Are you open to considering extending
the comment period?
Mr. Zeller. We have received multiple requests----
Senator Alexander. Yes.
Mr. Zeller. For extensions of the comment period, which we
are reviewing, literally, as we speak.
Senator Alexander. I would encourage you to do that. I
think it is more important to get this right, as you know very
well, because of your background. This is an extensive, complex
area.
Let me ask you a broader question. Where do you come down
on this difference of opinion on e-cigarettes? David Abrams at
the American Legacy Foundation, ``The single biggest
opportunity that has come along in a century to make the
cigarette obsolete.'' That is one point of view.
Dr. Frieden, ``Many kids are starting out with e-cigarettes
and then going on to smoke conventional cigarettes.''
Do we know enough to know yet what the impact of e-
cigarettes is?
Mr. Zeller. I need to answer as a regulator. We have
proposed to extend our jurisdiction over electronic cigarettes
that meet the statutory definition of a tobacco product.
We are also funding, literally, dozens of studies to answer
all the questions that we have about e-cigarettes and right
now, we have far more questions than answers about the safety
of the product, about what is in the product, about what is in
the vapor. We have questions about who is using the products
and how they are being used. It is a very complicated subject.
Senator Alexander. So you do not come down on either side
yet as to whether it is tool; more important as a tool to help
those who already smoke cigarettes to stop smoking or more
dangerous as a tool to encourage kids to start smoking?
Mr. Zeller. I think the only appropriate position for FDA
to take at this point is they have the potential to do good and
they have the potential to do harm. And we need answers to
questions, which we are funding through research.
Senator Alexander. When will you have enough answers to be
able to make the kind of decisions that you are expected to
make here?
Mr. Zeller. The first step in the process is having
regulatory authority over them. We do not need the answers to
those questions to complete the deeming rulemaking that we
launched several weeks ago.
But going forward, in terms of figuring out what regulatory
policies and approaches should be applied to e-cigarettes, when
they come within our regulatory reach, we need answers to those
questions. Let me give you an example of one of the studies
that we are funding.
We are spending a lot of money on what is called a
longitudinal study following the same people over time. It is
called the Population Assessment of Tobacco and Health and it
is following, literally, tens of thousands of adolescents and
adults. And over time, studies like that will begin to give us
information that answers some of the behavioral questions: who
is using the products, how they are being used.
We then need additional studies on the products themselves,
product safety. There are a series of questions that have been
raised about these liquid nicotine products and exposure to the
nicotine in these liquid nicotine products.
When we have answers to those kinds of questions, we can
figure out how to use the many regulatory tools that Congress
has given the agency to figure out an appropriate regulatory
framework to regulate e-cigarettes. But it starts with having
the authority to regulate them, which is what the deeming
proposal is all about.
Senator Alexander. My time is up. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Alexander.
Senator Burr.
Senator Burr. Thank you, Mr. Chairman.
Director Zeller, do you believe that some tobacco products
present greater risks to individuals than other products?
Mr. Zeller. Yes.
Senator Burr. OK. On the continuum of risk, do you believe
that noncombustible tobacco products are more likely to reduce
harm than a smoked form of tobacco for individuals who would
otherwise be using a conventional cigarette?
Mr. Zeller. The answer is that it depends upon who was
using the product and how they are being used. You can take any
non-combusting product, whether it is a smokeless tobacco
product, an e-cigarette, and it really depends upon who is
using them and how they are being used.
If we look at a subset of smokers who are otherwise unable
or unwilling to quit, they are going to continue to smoke that
pack of cigarettes. Half of them will die prematurely later in
life from that decision. If we could get all of those people to
completely switch all of their cigarettes for one of these
noncombustible products, that would be good for public health.
But our job as the regulator is to figure out what is going
on at the population level, and it includes the much larger
group of smokers--not like the first group I defined--a much
larger group of smokers who are concerned about their health,
and who are interested in quitting. And what happens instead of
those people completely substituting with a noncombustible
product, they start using both. And then along the way, they
wind up being less interested in quitting.
Then we would say, that might not be good for public health
and our job is to figure out what the net is of all of those
possible behaviors, including any initiation, which would not
be good for public health, and then try to make regulatory
policy on top of that.
Senator Burr. Mitch, for the adult that chose Nicorette 5
years ago, and they chewed the gum, and then they went out back
and they had a cigarette. And they could not smoke at work, so
they chewed the gum, and they went out back, and had a
cigarette.
Does that mean that Nicorette is not a useful tool for that
individual? It is only a useful tool if that individual uses it
to quit?
Mr. Zeller. Yes. I would absolutely concede that any of
these products, at an individual level, can do good.
What is challenging for all of us dealing with the law that
you gave us the responsibility to implement and enforce is the
decisions that we have to make are not going to be made about
what might be good for the theoretical individual. We have to
have regulatory science to support decisions that inform what
is happening at a population level.
So, we have to look at all possible behaviors.
Senator Burr. Yes, but if your trend line is this way, then
the public health effect is better. You have less people using
combustible products. You have more of those individuals that
have either quit or they have gone to a reduced harm product
that is good for public health.
And let me just say for the record, CVS eliminated their
cigarettes. CVS still sells patches, Nicorette gum, probably
all of the pharmaceutical products--Chantix and others--that
aid in eliminating or reducing the rate of smoking. It is not
like they threw out the whole category.
So take the retailer that sacrificed some large amount of
sales, they still believe that risk reduction is an important
thing for them to endorse. Would you agree?
Mr. Zeller. I would answer it in this way, Senator. The
products that you are referring to have been approved by FDA as
safe and effective medications, and they have been on the
market for over 30 years. There is a robust evidence base to
know that those products work to help smokers stop smoking.
They are actually not approved for reduction. They are only
approved for abrupt cessation, but there is a robust evidence
base that shows that when marketed to help smokers quit, and
when used properly, people can succeed.
By contrast, to go to the questions from Senator Alexander
about what do you know and what you do not know, when it comes
especially to e-cigarettes, there is a lot more that we need to
know about the impact on reduction and the impact on cessation.
Senator Burr. I agree with you totally. But can you point
to any new innovation where we know right at the beginning
everything about it and that we could come to an assessment?
Now, I am hopeful that through your studies, you find this
product is safe. We do not want an unsafe product out there
that contributes to a different problem.
But if you find that it is safe, are we going to say the
same thing about e-cigarettes 10 years from now? ``Jeez, the
body of evidence says that this did a tremendous thing to
moving people off of combustible tobacco products.'' Is that
not a good thing?
Mr. Zeller. If we are going to regulate them as tobacco
products, which is what the Tobacco Center has proposed to do,
we have to find the claims that the new products are
appropriate for the protection of the public health. That is
not the safety and efficacy standard.
Congress gave us a very different standard to use when
using the tobacco authorities. And under the standard
appropriate for the protection of the public health, it is that
mix of behaviors that I was describing that we have to assess
and then make regulatory policy based upon. It is complicated.
Senator Burr. I certainly look forward to the science that
is produced on this. I just caution you and our friends at CDC
that if we kill technology and innovation, which is, in
essence, what some are attempting to do with electronic
cigarettes right at the beginning. ``Just stop it. No more. It
should not be sold.'' Then innovation is not going to play a
role in reducing the amount of Americans that smoke. It is just
not.
I think it is safe to say that when I look at diabetes
today, I look at other things that we would consider a public
health epidemic, innovation is going to give us the ability to
do it. I do not think it is going to be by going out and
eliminating whether they can go to McDonald's and buy a double
cheeseburger, and the CDC is not proposing that.
It is going to be innovation. It is going to be driving
technology. It is going to be coming out with products that
allow us to turn around the problem that they have.
I think that is what we are talking about here, and I look
forward to the work you are doing.
Mr. Zeller. Thank you.
Senator Burr. Thanks.
The Chairman. Thank you, Senator Burr. We will start
another round.
Last month's proposal to expand FDA's authority to include
more tobacco products marked an essential step forward. And
while I was heartened by the release of this long-awaited
proposal, I was also disappointed that the rule did not address
some of the most egregious practices of e-cigarette
manufacturers.
I mentioned in my opening statement that last month, along
with 10 of my colleagues, I released the finding of our
investigation into the marketing practices of nine commonly
sold e-cigarette brands. To say those findings were
disheartening, I think for me, is an understatement.
Among those findings, I know you will not be surprised to
learn, that six of the companies reported that they market e-
cigarettes in flavors that appeal to children and teens.
Flavors like cherry crush, and chocolate treat, and peachy
keen, and great mint.
Now, I would just say that anyone who claims that these
products are not explicitly targeting kids is clearly blowing
smoke. These are targeted to kids, not adults. I have some
examples here.
Here is one I pointed out earlier: Rocket Pop. In fact, I
have a chart. I had it blown up so you can take a look at it.
Rocket Pop. It has got a popsicle on front. Now, can anybody
say that they are trying to market that to adults?
The other one I have here, this is for that refill with
pink spots is Gummy Bear. I do not think I have Gummy Bear, but
it is there. Here is another one Cotton Candy. Here is for the
refillables Cherry Crush. The one I had earlier was Apple
Cranberry. Again, these are targeted to kids.
Congress knew what it was doing based upon, I think,
evidence that we had that they were using flavors in cigarettes
to go after kids. Forget about the prospect of whether e-
cigarettes are good or bad for adults, and can this be a step
towards cessation. We do not know all that yet, and that has
got to be learned. But is it safe to say that, when you are
talking about kids that maybe there ought to be some
restriction on these to kids?
Dr. McAfee or Mr. Zeller, I guess, why did FDA feel it was
important to hold off on restrictions on e-cigarette flavors
and marketing when they are clearly targeting kids? Why did FDA
hold off on that on the flavors?
Mr. Zeller. I appreciate the question and the perspective,
Mr. Chairman, and we share the concerns about any marketing of
any of the currently unregulated products like e-cigarettes
that would have an appeal to kids.
We need to have jurisdiction over them to do something
about it, but in the preamble to the proposed deeming rule that
would give us the authority to take regulatory action, we
summed up all the evidence that we had about flavors. Then we
asked a series of, what I think, are very profound and far-
reaching questions that we want comment from, from all points
of view on what role the presence of flavors like this should
play as an influence on the regulatory policies that the Agency
will be in a position to make when deeming is final, and we
have the ability to use all manner of tools.
Technically, to ban flavors requires the issuance of
something called a product standard under a different section
of the statute; it is a separate rulemaking. But we need
answers to the questions that we posed about what role should
the flavors play in how these products are regulated.
The Chairman. Let me take a different line. Does FDA have
authority to regulate drug delivery devices?
Mr. Zeller. FDA first tried to regulate e-cigarettes as
drug delivery devices and we were struck down by the courts in
the absence of a cessation claim.
The very first action that FDA tried to take on e-
cigarettes back in 2008 and 2009, before the Family Smoking
Prevention and Tobacco Control Act passed, was an enforcement
action to prohibit the importation of e-cigarettes as
unapproved drugs and devices. We were sued by an importer and
the importer won in court. And in 2011, we had to announce that
we would create a regulatory framework for e-cigarettes under
these tobacco authorities in the absence of a cessation claim.
The Chairman. I guess I do not understand it. Is nicotine
generally recognized as a drug?
Mr. Zeller. Yes.
The Chairman. It is an addictive drug, is it not?
Mr. Zeller. It is.
The Chairman. Does not an e-cigarette deliver a nicotine
vapor to your body?
Mr. Zeller. We can make the assumption that it does. We
need more information about that, but we can make the
assumption that it does.
The Chairman. I mean, you puff on it and you get nicotine.
I mean, what else would you do? You do not throw it on the
ground. It is put in there and you inhale it.
Mr. Zeller. I can only tell you what----
The Chairman. It is a delivery device.
Mr. Zeller. I can only tell you what the courts ruled. We
tried to regulate e-cigarettes in exactly that way and we were
overruled by the courts.
In the absence of a claim, a medicinal claim, a therapeutic
claim, the courts told FDA, the only way that we could regulate
nicotine containing e-cigarettes was under the tobacco
authorities, and that is because of a statutory definition of a
tobacco product. It has two parts, something that is either
made or derived from tobacco, and the nicotine in e-cigarettes
is derived from tobacco.
The Chairman. Right.
Mr. Zeller. And the courts said in the absence of a drug
claim, the only way we could regulate tobacco-derived nicotine
in these products was under the tobacco authorities.
The Chairman. The reason I had all these out here today,
just to show the proliferation of the devices that are going to
kids. Here is one that is 800 puffs, delivers something that is
a can-apple.
It is interesting, they say on the back in fine print, it
says--it is called an ``electronic hookah'',
``Electric hookah'' is not approved by the United
States Food and Drug Administration. You must be of
legal tobacco purchase age according to State law to
purchase and use these products. This product has not
been tested or proven to aid in smoking cessation and
the product contains nicotine, which is an addictive
and toxic substance and must not be used by pregnant or
nursing women and nonsmokers. Keep this product out of
reach of children.''
But we know kids are getting them. They are buying them.
They are proliferating among high school students. They are
buying these fancy things here. They have a plug that goes into
the wall. It looks like a computer plug. It has the little
computer device that goes in there and you stick your thing in
there and recharge it. They are rechargeable. I do not know
what that costs. I am told this costs about $10 bucks and you
get 800 puffs on $10 bucks. But these are all geared toward
young people and I had that out just for show.
I heard you say we need a longer comment period. I do not
know about that. Something has got to be done about this.
Mr. Zeller. Let me tell you other parts of the proposal
that would address the issue of youth use of these products. We
proposed extending the minimum age of sale that currently
exists for cigarettes, smokeless tobacco, and roll your own to
e-cigarettes. And so retailers who sold e-cigarettes to minors,
if this proposal goes final, would be violating our regulations
and Federal law.
We have proposed to ban the sale of any of these products
in vending machines to the degree that there are vending
machine sales, unless it is in an adult-only establishment.
And on the issue of nicotine and addiction, we have
proposed a warning label on all of these products that explains
to the public that they contain nicotine and that nicotine is
addictive. The comment period is the public's opportunity to
make suggestions for additional things that we should be
thinking of doing when our rule goes final.
The Chairman. That is interesting. This has a lot of that
stuff I told you in fine print on the back, but none of this
stuff does; nothing on it.
Mr. Zeller. And that is because they are not currently
regulated by FDA.
The Chairman. But it is concentrated nicotine, an addictive
drug. I went way over my time. I will yield.
Senator Alexander. Thank you, Mr. Chairman. I have no more
questions, and I have an appointment that I have to go to. But
I certainly have no objection to your continuing.
The Chairman. Do you mind if I continue?
Senator Alexander. No, sir.
The Chairman. OK. Thank you very much. I want to change
things here a little bit.
Dr. McAfee, one of the most startling findings of the
recent Surgeon General's report was that cigarettes are more
dangerous today than they were when the first Surgeon General's
report on smoking was issued 50 years ago. That was startling.
The report indicates that cigarette smokers today have a
higher risk for lung cancer than smokers in 1964 despite
smoking fewer cigarettes. And that some, if not all, of this
increased risk is likely caused by changes in the composition
and design of cigarettes.
Can you explain ways in which these cigarettes are more
dangerous?
Dr. McAfee. Sure. I would add that the other thing that I
think we have found very disturbing around this, in some ways,
unexpected finding, is that it does raise concerns about the
ability of innovation to automatically lead to improvements in
public health without regulation, because over the last 50
years, until the FDA got authority 4\1/2\ years ago, cigarettes
were entirely unregulated.
The remarkable thing that happened was that the innovations
that were put in place by--apparently some of the innovations
that were put in place that affected composition and design of
cigarettes did not lead to fewer deaths. Most of the
innovations appear to have been more driven for other purposes.
And that the things that we have found, and a lot of this
is basically driven by epidemiologic findings, is that despite
the fact that we are smoking fewer cigarettes, a person who
smokes in the United States is more likely to develop lung
cancer than they were 30 or 40 years ago.
The Chairman. I am sorry. Excuse me.
Dr. McAfee. Sure. No problem. There has been a specific
change that we absolutely think is related to changes in the
design composition and that is that the type of cancer that
people develop, the common lung cancer----
Way back when I was in medical school the most common form
of lung cancer was squamous cell carcinoma, which was found
close-in to the main branchings of the lung. And over the last
few decades, this has shifted to another kind of cancer called
adenocarcinoma, which is located in the periphery of the lungs.
And we believe that this is due, essentially, to the fact
that cigarettes, over the last 30 or 40 years, have become
easier to inhale due to changes in their design and
composition. That may range from everything from the light,
low, mild changes in the nature of their composition to design
changes like ventilation holes in filters.
We are not entirely sure what it was, but the Surgeon
General determined that this change was related to design and
composition changes.
The Chairman. So the technology was used to make a
cigarette that was easier to inhale and contain substances that
were more dangerous?
Dr. McAfee. Whether they contain more substances that were
actually more dangerous or they literally just allowed the
smoker to inhale them more deeply than they previously were
inclined to do because the cigarettes 50 years ago were
harsher.
What we are viewing, what we are seeing in terms of the
numbers is very large increases in the risk of lung cancer;
larger in women than in men, but very large in both. Cigarettes
have actually become--at least the way that cigarettes are
being used and smoked in the United States--have become more
dangerous, not less dangerous.
The Chairman. Mr. Zeller, again, 5 years since we passed
the Family Smoking Prevention and Tobacco Control Act. Again, I
think a truly historic achievement for public health, but I
know there have been some delays in implementing some
provisions. But I also recognize that thanks to the ability of
the FDA to regulate these products, strides have been made
during that time. The Center for Tobacco Products has been,
obviously, key. That is who is charged with this
responsibility.
What have been some of the best accomplishments, perhaps
some of the biggest challenges confronting the Center for
Tobacco Products?
Mr. Zeller. In terms of accomplishments, it was no small
task to start with literally 2 full-time employees at the end
of September 2009--two--accompanied by about 20 other people
who were temporarily on loan to this brand new Center. So it
was no small task to literally build the Center into what it is
today.
It is a full-fledged, regulatory entity doing compliance
and enforcement, doing public education, doing major work in
terms of reviewing product applications, and overseeing
investments in research because as I said in my remarks, we are
a regulatory Agency. We can only go as far as the regulatory
science will take us.
The regulatory science informs all the decisions that we
make on product applications, all the policies, guidances,
regulations that we could be issuing.
On the accomplishment side of the ledger, having a fully
functioning Center that is doing all of that and that has
launched the Real Cost campaign, and that is doing a massive
nationwide enforcement of youth access laws, making a major
investment in research, and making progress on the product
review submissions, would be the short list of accomplishments.
There have been challenges for the very same reason that we
literally started from nothing in 2009, there were challenges
with the product submissions. No question.
We can look at it from both sides. There were problems with
the submissions. Many of them were incomplete, but we have to
own part of that as the regulator as well. It took us time to
get up to speed. It took us time to hire all of the scientists,
and especially chemists and engineers. We really needed some
specialized science capability to do the best possible product
reviews. But we have made extraordinary progress in dealing
with the queue of applications.
On the challenges side, it is what comes with literally
starting from nothing, inheriting, as I said, over 20
mandatory, statutory deadlines, and then doing the best
possible job that we could with the product submissions.
I can report that we have made extraordinary progress on
the product submissions. There is a concept known as
substantial equivalence. It is one of the pathways to market
that companies can submit applications for. And for the queue
of substantial equivalence applications for products not
currently on the market, review of new applications can begin
as soon as an application is received, and we could not have
said that a year ago, 2 years ago, 3 years ago. There is more
progress to be made, but I think that we are meeting some of
the greatest challenges that we have faced.
The Chairman. I appreciate that.
Then let us talk a little bit about warning labels. One of
the key provisions was calling for larger warning labels on
cigarettes and smokeless tobacco products. The smokeless
warning labels requirement, I guess, has been implemented.
However, the specific graphic warning labels proposed by FDA,
again, were struck down by a court, the U.S. Court of Appeals
here for the D.C. Circuit on First Amendment grounds.
After that decision, I wrote to Commissioner Hamburg urging
FDA to move quickly to develop and implement a strong, new
graphic warning labeling rule. Indeed, FDA's general authority
to require graphic warning labels has been affirmed in the
courts.
So given the evidence that graphic warning labels encourage
smokers to quit and prevent nonsmokers from starting to smoke,
I am hoping this is a high priority for FDA.
Is FDA going to propose a new set of cigarette warning
labels that are designed to withstand a constitutional
challenge?
Mr. Zeller. The priority, and we are doing this, is getting
the research done to inform our ability to write a new rule to
survive the likely litigation that would come. Getting that
research done is one of our highest priorities.
And armed with the results of that research, and with
paying attention to the court decisions that have come in, in
reviewing our first attempt, which was struck down, will
require some careful deliberations. And we will do that, just
as soon as we can complete the research. But getting the
research done to support a new, graphic warning label rule is a
very high priority of the Center and the Agency.
The Chairman. I wish we had some labels like I see in our
neighboring country to the north in Canada. They have some
pretty graphic and strong labels; full package on it. I guess
they do not have a Constitution like we have that they have to
worry about, but they are great warning labels.
Does FDA plan to exercise its authority in the area of
standards to require changes in cigarettes and other tobacco
products, for example, limiting tar and nicotine levels to make
them less addictive, less harmful, or less attractive?
Mr. Zeller. Are you referring to the authority in the law
known as Product Standards?
The Chairman. That is right, product standards.
Ms. Zeller. Product standards is one of the most powerful
tools that Congress gave the agency in the Tobacco Control Act.
It is the power with one exception. It is the power to ban or
restrict the allowable levels of ingredients, constituents in
the finished product.
we have been saying publicly that we are investing in
research to explore potential product standards in three areas,
and this is as far as I can go publicly. We are supporting
research to explore potential product standards in the areas of
addiction, toxicity, and appeal. And armed with that
information, we will then explore our regulatory options.
The Chairman. Good. Good, good.
My last question, Dr. McAfee, I want talk about cessation
services. Last year, I wrote to Secretary Sebelius because I
had a concern that many private health insurance plans were not
covering tobacco cessation services that are recommended by the
U.S. Preventive Services Task Force and required under
provisions that I authored in the Affordable Care Act.
Earlier this month, the Department issued guidance
clarifying for insurers exactly what evidenced-based tobacco
cessation services must be covered without co-pays or
deductibles as the law requires. We know that a combination of
medication and counseling is most effective at helping tobacco
users quit.
Could you elaborate on the role of cessation services in
stemming the tide of tobacco use, and whether you expect this
guidance to provide improved access to such services?
And second, do you have any suggestions on the best way to
increase the number of doctors who talk to their patients about
quitting and increase the number of smokers who are covered
under the cessation services?
Dr. McAfee. Thank you very much, Chairman Harkin, for that
question.
It is a question that is near and dear to me because one of
the things that I did prior to coming to CDC was to work very,
very hard as a primary care doctor within an integrated
healthcare system basically to try to figure out how we could
mobilize the engine of healthcare to help our patients quit
smoking. And this has proven to be something that has lots of
very strong potential, but also lots of very strong challenges.
And the potential is basically 75 percent of smokers see a
doctor in a year, and doctors have a lot of respect, and they
also are embedded in a system that increasingly knows how to
adopt changes and influence behaviors.
But on the flip side, there have been prodigious obstacles
to moving forward around this including the lack of training
that medical professionals get to help their patients, and then
particularly the lack of coverage and capacity to be able to
provide services without it seeming like something that they
are doing just as, on top of everything else, as opposed to
something that is integral to care.
The short story that I learned from my decade of trying to
do this is, yes, it is possible. It takes a lot of work. You
have to make services accessible so that clinicians can refer
people out to get deeper levels of service.
We spent a lot of time trying to buildup services like the
1-800-QUIT-NOW as an option for clinicians. And, you have to
figure out ways that they can have the time, get reimbursed for
it, et cetera, and then it really does work. You can actually
drop prevalence at a population level.
There were very, very exciting experiences in Massachusetts
in Medicaid, for instance, where they were able to drop
prevalence in just a few short years by major promotion of a
good benefit.
The exciting elements associated with the Affordable Care
Act are really that it has, as you noted, embedded in it
requirements about barrier-free coverage. There has been a
devil in the details challenge around how that actually gets
translated into language and guidance to health plans so that
they are able to do that, encouraged to do that, required to do
that.
I do think that the guidance that HHS released last month
gets a bit more specific around this. This is what the health
plans actually were saying that would be helpful to them and
that many of them will move. It will continue to be a process,
but one that has hope.
We have tried to integrate this in with the Tips from
Former Smokers campaign and have gotten a lot of interest from
healthcare organizations.
The Chairman. I just guess I wish we had more emphasis, and
I am going to be looking at this too, that people who are
covered under the Affordable Care Act that see their doctors on
prevention and wellness with no co-pays, no deductibles, they
go in and get their annual checkup. That doctors have in their
list of things that they do is to advise them on smoking if
they smoke; to advise them on not only why they should quit,
but how they should quit, what is available to them to help
them; and refer them to the quit lines; refer them to other
activities that they might do to cease. And then, if they need
medication, or the patches, or the gum and stuff like that, to
be able to advise them and get them on those. That is what I am
hoping we do.
Dr. McAfee. I strongly agree. We have actually done a
pretty good job over the last 15 years, say, of getting it so
that people are asked about their tobacco use status and given
brief advice by physicians.
But we still have a ways to go to try to make it so that
particularly if people are interested, which most people are,
that they can gain access to help everything from counseling
right on the spot, to referral for counseling, or phone
counseling, or Web counseling, and to medications. Just having
it more embedded the way we treat hypertension, cholesterol, or
the management of diabetes; having it just be part of service.
The Chairman. I want to just add one more thing before I
close up here, and that is the issue was raised earlier about
premium cigars.
Then I read somewhere about more and more kids are smoking,
not what you think of as a cigar, but they are like little
cigarettes, but they are cigars. They are wrapped in cigar
paper and they are little, small cigars. And those are also, I
think, being flavored too, if I am not mistaken. Yes, some of
those are being flavored. So there is a clear distinction
between that and premium cigars.
And you said to me as you are working on a rule and how you
define what a premium cigar is. I do not know what it is
either, but I just hope that there is a clear delineation
between those. Between that, which kids do not use, and which
they cannot afford to buy, and they are too expensive, and the
ones which they do get hooked on, those little cigarillos or
whatever they are called.
Mr. Zeller. And to point on flavors, one of the elements of
our proposed definition for a premium cigar is that the only
flavor that is in there is tobacco.
The Chairman. Are there premium cigars with flavoring?
Staff. Yes.
The Chairman. Oh, there are premium cigars with flavoring.
Mr. Zeller. We are proposing that the only flavor that can
be in a premium cigar is tobacco, but we will welcome to take
comments on that.
The Chairman. Yes, I do not know that either. It is like
that old saying, ``I know it when I see it.''
Mr. Zeller. Right.
The Chairman. You know a premium cigar when you see it, but
it is hard to define.
Mr. Zeller. It is hard for a regulator to take that
approach, though.
The Chairman. That is very true. I appreciate that.
Dr. McAfee. If I could just add a word or two around that,
I would want to make sure that we emphasized the reality that
all cigars are dangerous. They all contain most of the same
toxic substances.
We are burning tobacco and that creates thousands of
chemicals including around 70 or 80 carcinogens, most of those
worrisome chemicals that are present in cigarettes are also
present in cigars, including premium cigars. There may be some
differences in how they are smoked, et cetera, but it is still
a dangerous product and the question of how it should be
regulated is different from the question of whether it should
be regulated; whether they should be regulated.
The Chairman. Got that.
The other thing I just want to say is I had all this stuff
on the e-cigarettes and, again, I'll just re-emphasize that the
way they are being marketed, they are being marketed to kids
and it is nicotine. Nicotine is an addictive drug. So they are
marketing an addictive drug to kids, which gets them addicted
on nicotine.
If they cannot get a hold of one of these or one of those
when they are addicted, they will get a hold of cigarettes. It
just almost seems to me like this is almost like a gateway kind
of an approach to cigarette smoking. So I urge you, I hope
that----
Again, I do not know about extending the comment period,
whether that needs to be done, but I sure hope we do not kick
this can down the road any more. We have got to get a handle on
this one and start nipping this in the bud, this e-cigarettes
stuff.
What you do on it with adults, I am a little less clear on
that, but for kids, as far as I am concerned, pretty clear what
is happening here and how they are marketing it.
Now, do either one of you have anything else that we have
not asked, or covered that you would like to make for the
record, or have us think about? Is there anything we have not
asked or covered that you would like to add?
Dr. McAfee. I would actually just like to followup a little
bit on one of the things that you had said about e-cigarettes.
I think one of the things that has been misunderstood about
our findings last September at CDC is that there is some
implication that we have to prove that children who use e-
cigarettes will progress in some large, dramatic fashion
automatically to cigarettes, and we think that is a red
herring.
It is essentially related to what you just said. It is an
important thing to find out, and we look forward to the
findings from the pad, but the bottom line is for at least
three reasons, children should not be using e-cigarettes.
And we, as a society, there is no necessity for us to
require marketing, sales, and product characteristics that will
result in millions of kids experimenting with e-cigarettes. As
you noted, nicotine is addictive.
The other thing that we are worried about is even if kids
were not to progress to cigarettes, we do not need to have e-
cigarettes to get kids to not smoke. We have plenty of other
societal tools that have proven to be very effective. We can
get youth-use down into low single digits doing stuff.
It is egregious to suggest that somehow we need to have
kids do this in order for adults to quit. And we are very
worried because the Surgeon General's, this most recent Surgeon
General's report, one of its findings around nicotine was that
it is strongly suggestive that it has deleterious effects on
the development of the adolescent brain. And this is not
something that we need to, or should, fool around with.
And then the last issue is, in fact, we are not saying that
it is a gateway, but we have ample reason to be anxious and
concerned that one of the results of millions of kids, if it
becomes millions, playing around with e-cigarettes, especially
if the reason that they are fooling around with e-cigarettes is
because they are watching advertising and promotions that are
renormalizing tobacco use, by making it sexy, glamorous, and
using celebrity endorsements on television.
This is a huge experiment and it is not fair to our
children to ask them to pay a potential price around that for a
hypothetical benefit to adult smokers. And we know the tactics
that are being used in the process of marketing e-cigarettes,
half a dozen characteristics of them that are very similar to
the same things that a 2012 Surgeon General's report found,
that the tobacco companies that had engaged in that caused kids
to--that increased the chances that they would smoke
cigarettes.
We do not think that we can afford to or that there is any
necessity to literally spend 5 or 10 years proving that a 13-
year-old using e-cigarettes will lead to them using cigarettes.
It is just purely a bad idea.
The Chairman. You are saying, basically, they are dangerous
in and of themselves, whether they are a gateway or not.
Dr. McAfee. Correct. Even the idea of a gateway, it is
somewhat of a misnomer because a gateway in substance abuse
treatment is that if you use one drug, it will lead to another
drug. Like if you use marijuana, maybe it will cause you to use
cocaine or heroin.
This is the same drug. It is nicotine. It is just a
different delivery device and the drug itself is intrinsically
of concern in adolescents.
The Chairman. Got it.
Mr. Zeller.
Mr. Zeller. Just one closing thought. Absolutely understand
the concerns that you and Dr. McAfee have expressed about e-
cigarettes and especially the degree to which, any degree to
which they are enticing kids.
I will just leave you with one big picture thought. Let us
not lose sight of the fact that this remains the leading cause
of preventable death and disease in our country principally
because of combusting cigarettes. And the opportunity that
Congress has given the Center for Tobacco Products with the
authorities and the resources that you have given us is an
opportunity to make a serious dent in that death and disease
toll.
Now that we can add the tools of product regulation and the
impact that product regulation can have to national
comprehensive tobacco control efforts, let us not lose our
focus on what that primary cause is for those now more than
480,000 avoidable deaths each year, and that is primarily
burning combusting cigarettes. And we need to redouble our
efforts to focus on that.
Dr. McAfee. And if I might just re-emphasize the very
important point that Mitch Zeller made along these same lines,
the Surgeon General's report really emphasized this point that
we can argue, and we will, about how e-cigarettes should be
regulated, velvet glove-iron fist, how should this happen, and
which particular policies.
But the safest thing that we can do, the biggest way that
we can minimize their dangers and potentially maximize any
potential benefits they have is,
``The impact of the noncombustible aerosolized forms
of nicotine delivery on population health is much more
likely to be beneficial in an environment where the
appeal, accessibility, promotion, and use of cigarettes
and other combusted tobacco products are being rapidly
reduced, especially among youth and young adults.''
The Chairman. In other words, if e-cigarettes were marketed
like the patch.
Dr. McAfee. Or if cigarettes, if the appeal, accessibility,
and promotion, and use of cigarettes were thumb-screwed in a
more dramatic fashion.
The Chairman. I am concerned about this approach now
because I know there is a debate on whether e-cigarettes is a
smoking cessation device or does it lead to youth to become
more addicted to nicotine. I have seen a lot of back and forth
on this.
If you control the marketing so that e-cigarettes are
simply marketed or sold under the same provisions like a patch
or Nicorette gum, that is one thing. But that is not what is
happening.
Mr. Zeller. All I can say, Mr. Chairman, is that we tried
that and the courts said no. We tried that.
The Chairman. You tried to regulate e-cigarettes?
Mr. Zeller. We tried to regulate e-cigarettes as unapproved
drugs and devices, and we took an enforcement action, and we
were sued, and the courts sided with the company that sued us
and said, ``In the absence of a claim, a cessation claim,''
which would automatically make it subject to regulation by FDA
under the safety and efficacy standard as a drug and device.
In the absence of a cessation claim, the courts ruled that
the only way that we could regulate e-cigarettes is under the
tobacco authorities because the nicotine in these products is
derived from tobacco and that is the regulatory framework that
we are trying to create starting with the deeming proposal.
The Chairman. I will have to think more about that. Just a
moment.
[Pause.]
Yes, I guess you are right. The courts made a bad decision.
Anyway, thank you both for all your leadership in this
area. We just cannot let up on our efforts, and we have to
figure out some way of getting a handle on these e-cigarettes,
especially as it pertains to kids.
I do not know whether I am for extending the deadline on it
or not. I do not know. All I know is that there should be some
really compelling reasons to extend the deadline beyond 75
days. I do not know if there are or not; I have not seen that
yet. Thank you all very much.
I ask that the record be open for 10 days for other
comments and suggestions from other members.
Thank you again, for being so patient, for being here, and
thanks for your leadership.
Mr. Zeller. Thank you, Mr. Chairman.
The Chairman. Appreciate it.
Dr. McAfee. Thank you.
The Chairman. Thank you. Thank you both.
[Additional material follows.]
ADDITIONAL MATERIAL
Department of Health & Human Services,
Food and Drug Administration,
Silver Spring, MD 20993,
March 27, 2015.
Hon. Lamar Alexander, Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC. 20510-6300.
Dear Mr. Chairman: The Food and Drug Administration (FDA or the
Agency) provided testimony at the May 15, 2014, hearing before the
Committee on Health, Education, Labor, and Pensions entitled,
``Progress and Challenges: The State of Tobacco Use and Regulation in
the U.S.'' This is a response for the record to questions posed by
several Committee Members to Mitchell Zeller, Director of FDA's Center
for Tobacco Products.
Please let us know if you have further questions.
Sincerely,
Thomas A. Kraus,
Associate Commissioner for Legislation.
______
Response of the Food and Drug Administration to Questions of Senator
Harkin, Senator Alexander, Senator Mikulski, Senator Murkowski, Senator
Roberts, Senator Burr, and Senator Casey
senator harkin
Deeming Rule
On April 24th, FDA issued a long awaited draft rule asserting
agency jurisdiction over additional tobacco products, including e-
cigarettes. This proposed ``deeming'' rule marked an essential step in
FDA's implementation of the Family Smoking Prevention and Tobacco
Control Act. While I know there have been a number of requests to
lengthen the comment period and otherwise delay the issuance of a final
rule, it is imperative to the public health that these regulations be
finalized and strengthened. This is all the more important because, as
drafted, the full force of the proposal would not come to bear for a
full 2 years after it is finalized.
Question 1. What steps can FDA take now to ensure issuance of a
final rule within a year?
Answer 1. The comment period for the proposed tobacco deeming rule
closed on August 8, 2014. We are carefully considering all of the
comments. FDA is also considering any data, research, and other
information submitted to the docket. Finalizing the deeming rule is a
priority for the Agency and we share your sense of urgency on this
important matter.
Mislabeled Pipe Tobacco
We tax different tobacco products at dramatically different rates
in this country--while roll-your-own tobacco is taxed at the same rate
of cigarettes, pipe tobacco is taxed at a much lower rate. Over the
course of the last 5 years, we've seen ill-intended manufacturers take
advantage of this disparity by relabeling roll-your-own tobacco as pipe
tobacco--while making it clear to consumers that the product is
intended for rolling into cigarettes. As a result, in 2012 GAO reported
that annual sales of so-called pipe tobacco increased 869 percent
between 2008 and 2011. The same report concluded that between 2009 and
2011, the loss of tax revenues due to pipe tobacco masquerading as
roll-your-own tobacco totaled as much as $492 million. I've authored
legislation that would eliminate this problem by equalizing tax rates
across tobacco products but FDA also has important tools.
Question 2. What has FDA done to address the issue of mislabeled
roll your own tobacco? Does FDA plan to take enforcement action, in
addition to the August 2013 warning letters that you sent, against
these companies under the misbranding provision of the Family Smoking
Prevention and Tobacco Control Act, through which Congress gave the
agency authority to address this issue?
Answer 2. To ensure regulated industry and tobacco products are in
compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act),
FDA conducts compliance check inspections of retailers; compliance
reviews relating to tobacco product document submissions; routine
surveillance of promotional activities of manufacturers, distributors,
importers, and retailers; and inspections of manufacturers, among other
activities. During the course of these compliance activities, if a
tobacco product is promoted and sold as a product that is currently
under FDA's jurisdiction (i.e., cigarettes, cigarette tobacco, roll-
your-own (RYO) tobacco, smokeless tobacco), FDA would determine whether
the product complies with the requirements of the FD&C Act and would
take an enforcement action if violations are found. Examples of
violations contained in Warning Letters issued by FDA include
violations of the prohibition on characterizing flavors other than
tobacco or menthol and violations of the restrictions on modified-risk
claims and descriptors. Even tobacco products that are labeled as pipe
tobacco may be found to be in violation of the law, if the product, due
to its labeling or promotion, meets the definition of cigarette tobacco
or RYO tobacco in the FD&C Act.
Pipe tobacco that is not promoted or sold as cigarette tobacco or
RYO tobacco is currently not subject to Chapter IX of the FD&C Act.\1\
---------------------------------------------------------------------------
\1\ Currently only cigarettes, cigarette tobacco, RYO tobacco, and
smokeless tobacco are subject to Chapter IX of the FD&C Act. On April
25, 2014, the Agency published the proposed rule entitled ``Deeming
Tobacco Products To Be Subject to the Food, Drug, and Cosmetic Act, as
Amended by the Family Smoking Prevention and Tobacco Control Act;
Regulations on the Sale and Distribution of Tobacco Products and
Required Warning Statements for Tobacco Products.'' Products that would
be ``deemed'' to be subject to FDA regulation are those that meet the
statutory definition of a tobacco product, including currently
unregulated marketed products, such as e-cigarettes, cigars, pipe
tobacco, nicotine gels, waterpipe (or hookah) tobacco, and dissolvables
not already under FDA's authority.
---------------------------------------------------------------------------
As of September 30, 2014, FDA has issued 20 Warning Letters to
firms for the sale and promotion of adulterated cigarette tobacco and
RYO tobacco products labeled as pipe tobacco. FDA continues to take
enforcement actions, as appropriate, to ensure continued compliance
with the FD&C Act and FDA's implementing regulations. FDA's Warning
Letters are available to the public on our Web site, www.fda.gov, which
serves to educate the public and encourage voluntary compliance by
regulated industry.
Tobacco Track and Trace
The Family Smoking Prevention and Tobacco Control Act authorized
the Secretary to ``require codes on the labels of tobacco products or
other designs or devices for the purpose of tracking or tracing the
tobacco product through the distribution system.''
Question 3. What barriers do you see to the implementation of a
Federal track and trace program for tobacco?
Answer 3. CTP is taking a number of actions on issues related to
illicit trade and track and trace. For example, CTP has hosted a number
of listening sessions on track and trace and illicit trade with members
of the tobacco industry; has consulted with colleagues from the Alcohol
and Tobacco Tax and Trade Bureau (TTB), the Bureau of Alcohol, Tobacco,
Firearms, and Explosives (BATF), and other Federal agencies; has helped
the Centers for Disease Control and Prevention (CDC) plan special
meetings of experts on illicit trade and track and trace, ''which
included representatives from CTP and other Federal agencies; and has
sponsored a major report from the Institute of Medicine (IOM), released
in February 2015, on the characteristics of illicit trade markets
throughout the world and the various initiatives that have been
implemented to prevent and reduce illicit trade (including tracking-
and-tracing systems).
Multiple agencies within HHS, including FDA and CDC, are working to
address the issue of illicit trade at both the State and national
levels. All of these actions will help to inform CTP's efforts to
implement a track-and-trace system and to otherwise address illicit
trade issues. The IOM report will be especially valuable by increasing
our understanding of existing illicit trade characteristics and
mechanisms and the effectiveness of various responses, and how an
illicit trade in non-FDA-compliant tobacco products might differ, how
track-and-trace technologies might prevent that type of illicit trade,
and what other approaches are likely to be most effective. The IOM
committee was also asked to identify research gaps and potential
approaches to closing those gaps. Other challenges to implementing a
new Federal track-and-trace system include making sure that it will
work well with existing Federal, State, and local tobacco tax
collection systems and with related recordkeeping and track-and-trace
systems and procedures.
senator alexander
Question 1a. To not be regulated by FDA, a premium cigar must have
a price above $10 at retail--how does that work?
Answer 1a. In the proposed deeming rule, FDA included two options
for the categories of cigars that would be covered by the rule. The
first option proposes to regulate all products that meet the definition
of a tobacco product (except accessories of newly deemed tobacco
products), and would include all cigars. The second option proposes
defining a category of premium cigars that would not be subject to
FDA's regulatory authority. FDA has proposed several criteria for a
cigar to be considered a premium cigar and, therefore, exempt from the
deeming regulation, should FDA select option 2 for the final rule. One
of these criteria is that the cigar has a retail price (after any
discounts or coupons) of no less than $10. If a retailer sells a cigar
for less than $10 per cigar, the cigar would not be considered a
premium cigar and would not be exempt from the deeming regulation, even
if FDA selects option 2 for the final rule. FDA encouraged comments on
all aspects of the proposed rule, including the proposed criteria for a
premium cigar.
Question 1b. If one retailer were to have a sale and sell cigars
for $9.99,would that cigar manufacturer be in violation of the law and
all cigars of that type be misbranded?
Answer 1b. Under option 2 of the proposed rule, one of the criteria
that a cigar would have to meet to be considered a premium cigar would
be to have a retail price (after any discounts or coupons) of no less
than $10. If the retail price of the cigar were less than $10, it would
not be considered a premium cigar under this proposal. Therefore, the
cigar would not be exempt from the deeming regulation, even if FDA were
to select option 2 for the final rule; the cigar would be subject to
regulation and would have to comply with the FD&C Act's requirements.
We note that FDA specifically requested comment on this $10 price
point, and we will consider all comments when finalizing the rule.
Question 2. To avoid FDA regulation, a premium cigar must not have
``characterizing flavors''. What does that mean? There is flavor
information on the box? If the tobacco is aged in a whiskey barrel, is
that a characterizing flavor? If Cigar Aficionado were to describe
flavors in a cigar, would that affect whether the product qualifies for
the exemption?
Answer 2. The proposed criteria for a premium cigar under option 2
of the proposed rule is intended to capture those products that,
because of how they are used, may have less of a public health impact
than other types of cigars. The preamble does not otherwise further
define ``characterizing flavor'' for the purposes of this criteria.
However, FDA solicited comments on all aspects of the proposed rule,
including the proposed criteria for a premium cigar.
Question 3. More broadly, given the thorough documentation of harms
from smoking tobacco and addictive nature of nicotine in the proposed
regulation, do you believe FDA can exempt any product that is made from
or derived from tobacco from regulation given the mission of protecting
the public health?
Answer 3. FDA recognizes that all cigars are harmful and
potentially addictive. At the same time, it has been suggested that
different kinds of cigars may have the potential for varying effects on
public health, based on possible differences in their effects on youth
initiation and frequency of use by youth and young adults, among other
factors. We published the proposed rule with two options (option 1 to
include all cigars; option 2 to exempt premium cigars) for public
comment to solicit information regarding such issues as disease risk,
nicotine addiction, how premium cigars are used, and an appropriate
definition for premium cigars, if needed, in order to determine whether
it is appropriate to exempt premium cigars from the regulation. FDA
will examine all of the available information in order to make the
best-informed decision.
Question 4. I'm here to learn about these new products, like
electronic cigarettes, as they compare to products we know more about
such as cigars, smokeless tobacco, and cigarettes. Mr. Zeller, you have
written about the relative risks of different tobacco products for
individuals. Could you share your thoughts about the continuum of risk
related to tobacco products, and list some products such as traditional
cigarettes, premium cigars, smokeless tobacco, and electronic
cigarettes from most risky to least risky based on the data we have
now?
Answer 4. While FDA acknowledges that there may be products that
contain lower levels of toxicants than cigarettes, many provisions in
the Tobacco Control Act require FDA to make decisions after considering
the risks and benefits to the population as a whole, including both
users and non-users of tobacco products. The risk continuum is a
relevant consideration as regulatory policy is developed; however, the
variety of potential patterns of use render this a challenging
assessment.
There are distinctions in the hazards presented by various
nicotine-delivering products. The view has been advanced by some that
certain new non-combustible tobacco products (such as e-cigarettes) may
be less hazardous, at least in certain respects, than combustible
products, given the carcinogens in smoke and the dangers of secondhand
smoke. The Department of Health and Human Services (HHS), including
FDA, CDC, and NIH, are conducting studies that will assess
addictiveness and the relative toxicities of e-cigarettes and other
tobacco products. To the extent that scientific evidence demonstrates
that certain products are indeed less harmful than others at an
individual level, they could help reduce the overall death and disease
toll from tobacco product use at a population level in the United
States.
Cigarette smoking is the major contributor to the death and disease
attributable to tobacco use. The challenge for FDA, in considering
currently regulated products and any additional products that would be
deemed to be subject to the FD&C Act, is that regulatory policy under
the Tobacco Control Act (TCA) must account for the net public health
impacts at the population level. This includes impacts on initiation
and cessation, and an evaluation of product harm.
Ongoing research, both within HHS and elsewhere seeks to
characterize whether emerging technologies, such as the e-cigarette,
may have the potential to reduce the death and disease toll from
overall tobacco product use, depending on who uses the products and how
they are used.
Much remains to be learned about the risks of e-cigarettes to
health, as well as their possible benefits. E-cigarettes could be a
detriment to public health. e-cigarettes have the potential to re-
normalize smoking, encourage youth to initiate smoking, and/or prompt
users to continue or to escalate to cigarette use--in effect, reversing
the meaningful progress tobacco control initiatives have achieved to
date. Other reported e-cigarette risks include dermal exposure to
nicotine, childhood poisoning events, and physical harm from defective
products (such as exploding batteries). On the other hand, e-cigarettes
could benefit public health if they encourage people who would
otherwise not quit smoking to stop smoking altogether, while not
encouraging youth or others to start use of tobacco products or
encouraging former users to relapse back to tobacco use.
Question 5. There is currently a backlog of over 4,000
applications, and by some estimates, the deeming of cigars as tobacco
products alone could lead to 5,000-10,000 additional applications being
filed 2 years after the proposed regulation is finalized. How could you
possibly handle such a workload?
Answer 5. FDA has made significant progress in reviewing
substantial equivalence (SE) reports for currently regulated products,
and the Agency believes that this momentum will continue. The Agency
has increased staffing, taken steps to streamline the SE review
process, and established performance goals that include timeframes for
review of regular\2\ SE reports and review of exemption from SE
requests. We have been able to develop these performance goals because
of increased capacity, efficiency, and knowledge of the scientific
evidence needed to adequately review SE reports. As of September 30,
2014, 45 percent of regular SE reports had been resolved by a final
decision,\3\ either because FDA issued an Order letter (92
submissions), a Refuse-to-Accept letter (6 submissions), or because the
submission was withdrawn (361 submissions). FDA has issued a Scientific
Advice and Information Request Letter or a Preliminary Finding Letter
for 81 percent of the regular SE reports that are pending.
---------------------------------------------------------------------------
\2\ SE reports received before March 23, 2011 for new products
introduced to market between February 15, 2007, and March 22, 2011 are
considered ``provisional,'' and the products covered by those reports
can remain on the market unless FDA finds that they are ``not
substantially equivalent.' '' The other category is ``regular'' SE
reports (reports received on or after March 23, 2011). Products covered
by ``regular'' reports cannot be marketed unless FDA first issues an
order finding the product substantially equivalent and in compliance
with the FD&C Act.
\3\ Final decisions include refuse-to-accept letters, withdrawals
by an applicant, substantially equivalent (SE) orders, and not
substantially equivalent (NSE) orders.
---------------------------------------------------------------------------
FDA continues to move forward with additional improvements to the
tobacco product review program. We continue to hire and train new
staff, develop better IT systems for tracking submissions, and address
the scientific policy issues that result from developing a new
regulatory review program. We will continue to advance our efforts to
review and act on provisional SE reports while also working to meet the
performance goals for regular SE reports and modified-risk tobacco
product applications. We are committed to completing the review of
provisional tobacco products.\4\
---------------------------------------------------------------------------
\4\ If FDA issues an order that a tobacco product subject to a
provisional SE report is NSE, the product may not be legally marketed
and may be subject to enforcement action, including seizure.
---------------------------------------------------------------------------
We intend to continue to build on this experience as we review
premarket applications for newly deemed products. CTP is committed to a
consistent, transparent, and predictable review process and to
completing reviews in a timely manner.
Question 6. FDA has tiered the 4,000 applications at the agency,
which all are for products still in the market, into four tiers based
on the potential risk to public health. For the product applications in
the high-risk tier, representing the greatest potential risk to public
health, can you provide a timeline for when the agency will complete
its review and remove any products from the market if necessary?
Answer 6. In June 2012, CTP established four Public Health Impact
Tiers for provisional SE submissions, and in August 2012, CTP began
assigning submissions to these tiers to prioritize scientific reviews
for those products with the greatest potential to raise different
questions of public health. Tier 1 includes submissions for products
that have high potential for raising different questions of public
health; Tier 2 is for products with moderate potential; Tier 3 is for
products with low potential, and Tier 4 is for products with the lowest
potential. Because FDA has been prioritizing the review of those
provisional SE reports that are most likely to raise different
questions of public health, the initial reviews likely will be more
complicated and will have less predictable review timeframes. On
February 21, 2014, FDA issued the first ``not substantially
equivalent'' (NSE) orders for four provisional tobacco products
currently on the market. These products can no longer be legally
marketed. We continue to review provisional products and will act on
these as these reviews are completed.
Question 7. You propose not allowing electronic cigarettes to make
claims that e-cigarettes may pose less risk than traditional
cigarettes. A popular electronic cigarette company has a marketing
campaign using phrases such as ``Friends don't let friends smoke'' and
``Cigarettes, you've met your match.''Would these campaigns be
considered in violation of the proposed deeming regulation? Why would
we not want companies to market their products to smokers as a less
harmful alternative to smoking, rather than forcing marketing to appeal
to the whole population?
Answer 7. The proposed deeming rule would extend FDA's tobacco
product authorities (which currently apply to cigarettes, cigarette
tobacco, RYO tobacco, and smokeless tobacco) to all other tobacco
products, as defined in section 201(rr) of the FD&C Act, except the
accessories of such other tobacco products, and potentially premium
cigars (if FDA were to choose option 2 of the proposal). Such
authorities include section 911 of the FD&C Act, which prohibits the
introduction into interstate commerce of a ``modified-risk tobacco
product'' without an FDA order in effect. A tobacco product is
considered a modified-risk tobacco product under section 911(b) of the
FD&C Act if its label, labeling, or advertising explicitly or
implicitly represents that: (1) the product presents a lower risk of
tobacco-related disease or is less harmful than one or more other
commercially marketed tobacco products; (2) the product or its smoke
contains a reduced level of a substance or presents a reduced exposure
to a substance; or (3) the product or its smoke does not contain, or is
free of, a substance. In addition, a tobacco product is considered a
modified-risk tobacco product if its manufacturer takes any action
directed to consumers, other than by means of the product's label,
labeling or advertising, respecting the product that would be
reasonably expected to result in consumers believing that the product
or its smoke may present a lower risk of disease or is less harmful
than other commercially marketed tobacco products, or presents a
reduced exposure to, or does not contain or is free of, a substance.
Modified-risk tobacco products that are introduced into interstate
commerce without an appropriate FDA order in effect are adulterated
under the FD&C Act.
The modified-risk tobacco product provisions aim to ensure that
modified-risk claims, including those about the relative harms of
different products, are substantiated and supported by scientific
evidence. As Congress found, unsubstantiated modified-risk claims are
detrimental to the public health. We have seen this historically, with
``light,'' ``low,'' and ``mild'' descriptors leading consumers to
incorrectly believe that those products were safer. If the deeming rule
is finalized as proposed, e-cigarette manufacturers would be eligible
to file applications seeking authorization from FDA to market their
products as modified-risk products under section 911 of the FD&C Act.
CTP's review of electronic cigarette modified-risk claims would help to
ensure that those claims are substantiated and not misleading. CTP
would be able to issue modified-risk tobacco product orders to
applicants that meet the criteria described under section 911 (g) of
the FD&C Act.
Question 8. I am concerned about the newly deemed products where
substantial equivalence is not available because you believe that you
cannot set a new grandfather date. All products, such as e-cigarettes,
cigars, and water pipes will have to submit premarket new tobacco
applications. My understanding is that no one has submitted a complete
premarket new tobacco application, and the guidance outlines
requirements for randomized controlled trials to prove impact on the
public health. What data and scientific evidence does the agency have
that these newly deemed products should be held to a different standard
than those that were able to use the substantial equivalence pathway?
Answer 8. Section 910 of the FD&C Act provides three pathways that
new tobacco products can use to obtain marketing authorization: SE;
premarket tobacco application (PMTA); or exemption from SE. The
criteria for whether a product can use a particular pathway, and the
standard for FDA authorization under each pathway, are set forth in the
statute. With regard to those newly deemed products for which a PMTA is
submitted, as noted in the preamble to the tobacco deeming proposed
rule, it is possible that an applicant may not need to conduct any new
nonclinical or clinical studies to support a PMTA application. FDA
requested comments on this issue, as well as comments regarding the
proposed compliance policy for substantial equivalence applications and
PMTAs and other legal interpretations of the substantial equivalence
grandfather provision that FDA should consider. FDA also requested
comments as to what other information the Agency should consider to
help expedite review of PMTAs for tobacco products that contain fewer
or substantially lower levels of toxicants.
Question 9. Would FDA work with Congress and support a legislative
solution to allow FDA to set different substantial equivalence dates
for newly deemed products if necessary?
Answer 9. FDA is aware of new tobacco product categories that
entered the marketplace after the February 15, 2007, reference date in
the Tobacco Control Act, and that the SE pathway may not be available
to these newer products. FDA included a question in the proposed
deeming rule, requesting comment as to whether there are other legal
interpretations of the SE reference date provision that FDA should
consider.
To address concerns that such products would immediately be removed
from the market, FDA is proposing a compliance period of 24 months,
following the effective date of a final rule, for submitting a
marketing application under this pathway. FDA is also proposing a 24-
month compliance period for the submission of PMTAs. In addition, we
proposed to continue the compliance policy, pending review of marketing
applications, if those applications are submitted within the 24 months
after the final rule's effective date. As a practical effect of these
compliance periods, we would expect that most firms would continue
marketing their tobacco products, pending FDA's review of their
marketing applications.
Question 10. If an electronic cigarette manufacturer files
premarket tobacco applications for its products, but then a change is
made to those products, say a new supplier is used, would the
manufacturer have to re-file all new premarket tobacco applications?
What changes will result in new tobacco product applications being
filed if the substantial equivalence pathway is not available?
Answer 10. All tobacco products that meet the definition of a ``new
tobacco product'' under section 910 of the FD&C Act are required to
undergo premarket review by FDA. However, FDA expects that not all
PMTAs will require the same type or amount of data and information in
order to satisfy the requirements of section 910 of the FD&C Act. In
the proposed deeming regulation, we explain that we are seeking
information as to how the Agency might streamline review of new product
applications. We state in the proposed rule that in certain instances,
we expect that FDA will be able to determine that a product meets the
requirements of the FD&C Act using information that might be less
burdensome for a manufacturer to gather and submit to FDA. For example,
in some cases it is possible that an applicant may not need to conduct
any new nonclinical or clinical studies. We are seeking comment on the
types of information that manufacturers of certain categories of
products could use to support their PMTAs.
Question 11. Can you provide the total number of inspections of
retail facilities, including how many have occurred on Native American
reservations and how many have occurred off-reservation?
Answer 11. As of September 30, 2014, over 346,000 FDA tobacco
retail inspections have been conducted across 54 States and
territories.
Working with federally recognized tribes requires careful
consideration of the legal and political framework that the United
States has established with respect to Indian tribal governments,
including Executive orders. FDA also follows the HHS Tribal
Consultation Policy, which directs FDA to consult with tribes before
any action is taken that will significantly affect tribes.
CTP discussed its compliance and enforcement activities during a
Tribal Consultation webinar held on June 16, 2014. Also on June 16,
2014, CTP issued a Request for Proposal (RFP) for contracts with
federally Recognized Indian Tribe government agencies to assist with
inspections of retail establishments on Tribal lands, similar to the
tobacco retail inspection program utilizing contracts with U.S. States
and territories. CTP provided a technical assistance webinar for tribes
to learn about the requirements of this RFP and how to submit a
proposal. As of September 30, 2014, FDA awarded two contracts to tribes
to conduct tobacco retail inspections within their jurisdictions.
Question 12. Does the Center for Tobacco Products plan on approving
one or more training programs for retailers so that retailers have a
model to use to best comply with the law?
Answer 12. Retailers are encouraged to implement a training program
for their staff and to tailor their program to meet the needs of their
employees and business, taking into consideration the size of their
business and the products that they sell.
FDA understands that some retailers have established various
tobacco retailer training programs. The Agency does not currently
approve any retailer training programs, however, FDA intends to
promulgate regulations establishing standards for approved retailer
training programs.
The TCA established two schedules for the maximum civil money
penalties that can be assessed for violations of regulations issued
under section 906(d) of the FD&C Act, including violations of FDA
regulations at 21 CFR part 1140--one schedule for retailers that do not
have an approved training program and another schedule, with lower
penalties, for retailers with an approved training program. In
determining the amount of penalty the Agency will seek, CTP will use
the lower schedule for all retailers, whether or not the retailer has
implemented a training program, until regulations are developed that
establish standards for retailer training programs.
FDA has also issued a guidance entitled ``Guidance for Industry:
Tobacco Retailer Training Programs,'' which is available at
www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/
ucm218898.htm. This guidance contains examples of recommended elements
that may be helpful to retailers in designing and implementing a
training program.
Currently, FDA develops compliance training materials for
retailers, posts important information to its Web site, issues guidance
documents, meets with and presents before stakeholders, and has
established a comprehensive program for training on, and assistance
with, the requirements of the TCA. In fiscal year 2014, CTP delivered
five compliance training webinars for retailers and small businesses
covering topics relevant to tobacco product businesses. In addition,
FDA is developing a new retailer education campaign and will continue
to provide easy-to-understand, free educational materials online and by
direct mail that help tobacco retailers comply with the law. The
campaign currently provides materials in English and Spanish and plans
to expand to include additional languages in fiscal year 2015.
Question 13. How is FDA utilizing the ``Minor Modification''
exemption to allow companies to make certain changes without review?
What types of changes qualify for these exemptions? Will you consider
permitting changes that are beneficial to the public health, such as
reducing harmful and potentially harmful constituents, through this
fast track process?
Answer 13. Under section 905(j)(3)(A) of the FD&C Act ``[t]he
Secretary may exempt [a tobacco product] from the requirements of this
subsection relating to the demonstration that a tobacco product is
substantially equivalent . . .'' In general, among other requirements,
a new tobacco product may be found exempt from the requirements of SE,
if the tobacco product is modified by adding or deleting a tobacco
additive, or by increasing or decreasing the quantity of an existing
additive, where that change constitutes a minor modification to the
product. This requirement is found in section 903(j)(3) of the FD&C Act
and at 21 CFR 1107.1(a). The term ``additive'' is defined in section
900(1) of the FD&C Act:
``The term `additive' means any substance the intended use of
which results or may reasonably be expected to result, directly
or indirectly, in its becoming a component or otherwise
affecting the characteristic of any tobacco product (including
any substances intended for use as a flavoring or coloring or
in producing, manufacturing, packing, processing, preparing,
treating, packaging, transporting, or holding), except that
such term does not include tobacco or a pesticide chemical
residue in or on raw tobacco or a pesticide chemical.''
Additionally, FD&C Act section 905(j)(3)(A)(ii) states that one of
the criteria for finding a product exempt requires that the Secretary
determine that ``a report under this subsection is not necessary to
ensure that permitting the tobacco product to be marketed would be
appropriate for protection of the public health . . .,'' and FD&C Act
section 905(j)(3)(A)(iii) adds the requirement that the Secretary
determine that an exemption is otherwise appropriate.
FDA has issued regulations implementing this SE Exemption Pathway.
When a product change meets the requirements in the statute as
described above, FDA can exempt the product from the requirement to
demonstrate SE. In this event, the manufacturer can implement the
change after notifying FDA in accordance with section 905(j)(1)(A)(ii)
of the FD&C Act.
Question 14. FDA allows sampling of smokeless tobacco in age-
restricted facilities. What scientific evidence exists to support
restricting similar sampling of newly deemed products, such as e-
cigarettes and cigars?
Answer 14. Congress, by law, provided an exception only for
smokeless tobacco in age-restricted facilities from the general rule
banning free sampling. FDA believes that the free sample prohibition,
as applied to newly deemed products, would eliminate a pathway for
youth to access tobacco products, reducing youth initiation and,
therefore, short-term and long-term morbidity and mortality resulting
from use of these products. The IOM has stated that free samples of
cigarettes ``encourage experimentation by minors with a risk-free and
cost-free way to satisfy their curiosity'' (Institute of Medicine of
the National Academies, ``Growing Up Tobacco Free: Preventing Nicotine
Addiction in Children and Youths,'' 1994). Although the IOM was
speaking in the context of cigarettes, the same rationale would apply
to the proposed deemed products. In addition, the U.S. Court of Appeals
for the Sixth Circuit previously recognized that FDA has provided
``extensive'' evidence that free tobacco samples constitute an ``easily
accessible source'' for youth (Discount Tobacco City & Lottery, Inc. v.
United States, 674 F.3d 509, 541 (6th Cir. 2012) (citing 61 FR 44396 at
44460, August 28, 1996), cert. denied, 133 S. Ct. 1966 (2013)).
FDA solicited comments on all aspects of the tobacco deeming
proposed rule, including data and information on how this restriction
would reduce youth use of proposed deemed products.
senator mikulski
Question 1. It is currently estimated that one in five deaths can
be directly attributed to tobacco use. Smoking reduces life expectancy
by at least 10 years and the CDC has said that tobacco use results in
at least $133 billion worth of direct medical care costs each year. We
have tried imposing taxes and educating--even scaring--the public about
the harmful effects of tobacco use--but more needs to be done. As
Director of the FDA's Center for Tobacco Products, what do you propose
could be done to reduce tobacco use and address the tragic loss of life
and unnecessary costs to taxpayers that result? Are you ready to try
new actions?
Answer 1. Despite decades of efforts by HHS to reduce tobacco use,
it continues to be the leading cause of preventable disease and death
in the United States. Since enactment of the TCA, FDA has made
significant progress toward establishing a comprehensive, effective,
and sustainable framework for tobacco product regulation. These
accomplishments include:
Establishing an initial framework for industry
registration, product listing, and submission of information on
ingredients and harmful and potentially harmful constituents in tobacco
products and tobacco smoke;
Implementing and enforcing the statutory ban on cigarettes
with certain characterizing flavors;
Restricting access and marketing of cigarettes and
smokeless tobacco products to youth;
Implementing and enforcing the requirement that cigarette,
RYO, and smokeless tobacco product manufacturers seek FDA authorization
before marketing a new product or making modifications to existing
products;
Implementing and enforcing the FD&C Act's prohibition on
the use of marketing terms for regulated tobacco products that imply
reduced risk (such as ``light,'' ``mild,'' or ``low'') without FDA
authorization;
Developing a process for the review and evaluation of
applications for new tobacco products and modified-risk claims;
Utilizing a science-based approach that addresses the
public health issues raised by menthol cigarettes. FDA has taken
several actions related to menthol, including: issuing an advance
notice of proposed rulemaking seeking comments that may inform
regulatory actions by FDA; requesting comment on the Agency-prepared
report entitled ``Preliminary Scientific Evaluation of the Possible
Public Health Effects of Menthol Versus Non-Menthol Cigarettes'';
investing in research, such as on the effects of menthol in cigarettes
and launching a youth education campaign that includes menthol-specific
messages.
Collaborating with CDC and NIH in pursuing a research
agenda to better understand regulated products and patterns of tobacco
use to inform the development of regulatory policy. This includes
establishment of the Tobacco Centers of Regulatory Science, a program
designed to generate research to inform the regulation of tobacco
products, and the Population Assessment of Tobacco and Health study, or
PATH, which is a collaborative study with NIH designed to measure
tobacco use behaviors and health to inform product regulation. PATH is
a longitudinal study that intends to follow tens of thousands of people
age 12 and older in the United States, who use and do not use tobacco
products.
Implementing a compliance and enforcement program to
ensure industry compliance with regulatory requirements, such as
minimum age of sale in retail establishments throughout the United
States; and
Collaborating with CDC in establishing public education
campaigns about the dangers of regulated tobacco products.
CTP is well-positioned to build on the work of its first 5 years.
In June 2014, we announced five strategic priorities designed to use
the authorities in the TCA to have the greatest impact on the public
health. CTP's strategic priorities are:
Product Standards--This tool enables FDA to require
changes to product content or design, including banning or restricting
the allowable levels of harmful compounds in finished tobacco products.
Comprehensive FDA-wide Nicotine Policy--We will help
establish an integrated, FDA policy on nicotine-containing products
that is public health-based and recognizes that it is not the nicotine
that kills half of all long-term smokers, but the carcinogens and other
toxins in tobacco smoke.
Pre-and Post-Market Controls: Regulations and Product
Reviews--We are developing rules and guidance for industry and
improving the timeliness of product reviews.
Compliance and Enforcement--We will continue to build the
compliance and enforcement program for tobacco products, including any
products deemed under CTP's jurisdiction.
Public Education--We will collaborate with CDC to maximize
HHS' efforts to educate at-risk audiences on the dangers of tobacco
use.
FDA shares your sense of urgency, and we are committed to taking
bold and sustained action to reduce the death and disease caused by
tobacco use.
Question 2. The 50th anniversary Surgeon General's report found,
``The evidence is sufficient to conclude that the increased
risk of adenocarcinoma of the lung in smokers results from
changes in the design and composition of cigarettes since the
1950's.''
FDA has had the authority since 2009 to require changes in all
cigarettes to make them less deadly, make them less appealing to kids
or to reduce the addictive levels in the product. What steps will FDA
take to move forward with using this very important tool from the
Tobacco Control Act to reduce the death and disease caused by
cigarettes?
Answer 2. Section 907 of the FD&C Act gives FDA the authority to
issue tobacco product standards that are appropriate for the protection
of the public health, through rulemaking. For example, FDA could issue
a product standard that would reduce the harm, addictiveness, and/or
appeal of tobacco products, if appropriate for the protection of the
public health.
CTP, with input from HHS, is exploring the potential for product
standards in all three areas: addiction, toxicity, and appeal. CTP is
also funding research to address issues related to potential product
standards.
senator murkowski
I am concerned about recent data published by CDC showing a huge
spike in nicotine poisonings among small children related to e-
cigarettes. I understand from the American Academy of Pediatrics that
even a teaspoon of the liquid nicotine used to refill an e-cigarette
could be fatal if ingested by a small child. Yet, liquid nicotine is
not required to be sold in childproof packages, and the proposed rule
you put out last month makes no recommendations on child-proofing.
Question 1. Is the FDA doing anything to prevent child nicotine
poisoning? Is there a reason why the FDA did not include these
precautions in its proposed rule?
Answer 1. In the preamble to the proposed deeming rule, FDA
included discussion regarding the recent increased incidence of child
nicotine poisoning and the Agency's concerns regarding this issue. FDA
considers the deeming rule to be a foundational regulation, which, when
finalized, would allow the Agency to take further actions regarding
critical issues, such as protecting children from liquid nicotine,
related to the proposed deemed products. For example, FDA would have
authority to issue tobacco product manufacturing practice regulations
under section 906(e) of the FD&C Act. Such regulations could include
requirements regarding the packaging and storage of a tobacco product
such as liquid nicotine. In addition, under section 907 of the FD&C
Act, FDA would have authority to issue a product standard with
provisions related to components of tobacco products, such as liquid
nicotine refill cartridges. Sections 906(d) and 907(a)(4)(B)(v) also
afford FDA the authority to issue regulations restricting the sale and
distribution of a tobacco product, if FDA determines that such a
regulation would be appropriate for the protection of the public
health.
FDA Commissioner Margaret Hamburg wrote in a New York Times op-ed
on May 12, 2014, the following,
``Much remains to be learned about the risks of e-cigarettes
to health, as well as their possible benefits, particularly for
those smokers who have not been able to quit using deadly
conventional cigarettes.''
Question 2. Mr. Zeller, can you share your views on the various
levels of perceived risk and potential benefit related to various
tobacco products currently on the market?
Answer 2. While FDA acknowledges that there may be products that
contain lower levels of certain toxic chemicals than cigarettes, many
provisions of the TCA require FDA to make decisions after considering
the risks and benefits to the population as a whole, including both
users and non-users. The risk continuum is a relevant consideration as
we make regulatory policy. But the potential patterns of use make this
a challenging assessment.
There are distinctions in the hazards presented by various
nicotine-delivering products. The view has been advanced by some that
certain new non-combustible tobacco products (such as e-cigarettes) may
be less hazardous, at least in certain respects, than combustible
products, given the carcinogens in smoke and the dangers of secondhand
smoke. HHS including FDA, CDC, and NIH, are conducting studies that
will assess the addictiveness and the relative toxicities of e-
cigarettes and other tobacco products. To the extent that scientific
evidence demonstrates that certain products are indeed less harmful
than others at an individual level, they could help to reduce the
overall death and disease toll from tobacco product use at a population
level in the United States.
Cigarette smoking is the major contributor to the death and disease
attributable to tobacco use. The challenge for FDA, in considering
currently regulated products and any additional products that would be
deemed to be subject to the FD&C Act, is that regulatory policy under
the TCA must account for the net public health impacts at the
population level. This includes impacts on initiation and cessation,
and an evaluation of product harm.
Ongoing research, both within HHS and elsewhere, seeks to
characterize whether emerging technologies such as the e-cigarette may
have the potential to reduce the death and disease toll from overall
tobacco product use, depending on who uses the products and how they
are used. If such products result in minimal initiation by children and
adolescents while significant numbers of smokers quit, then there is a
potential for the net impact at the population level to be positive.
If, on the other hand, there is significant initiation by young people,
minimal quitting, or significant dual use of combustible and non-
combustible products, then the public health impact could be negative.
senator roberts
Question 1. The Center for Tobacco Products is imposing fines for
retailers that fail inspections, but they are imposing multiple fines
and alleging multiple violations for a single inspection. This seems to
be contrary to the provisions of the law establishing the Center for
Tobacco Products which specifically states that retailers must be
informed of all previous violations before being charged with an
additional violation. In addition, it doesn't make sense with the
penalty scale in the law that gradually increases fine amounts per
violation. CTP's policy of counting one failed inspection as multiple
violations could lead to a retailer losing his or her business or being
hit with an unaffordable fine due to the actions of one bad employee
without giving the retailer an opportunity to fix the problem. Can you
explain how imposing multiple fines for a single inspection is
consistent with the law?
Answer 1. FDA charges a person with a violation at a particular
retail outlet only after providing notice to the retailer of all
previous violations identified by FDA at that outlet, as required under
section 103(q)(l)(D) of the TCA. Further, TCA section 103(q)(l)(E)
states that the maximum civil money penalties (CMPs) for multiple
violations shall increase from one violation to the next violation,
pursuant to the penalty schedule provided in the law.
As noted in the June 2014 revised Guidance for Industry entitled
``Civil Money Penalties for Tobacco Retailers: Responses to Frequently
Asked Questions,'' the first time FDA identifies violation(s) at a
retail outlet, its policy is to send a Warning Letter. CTP counts only
one violation from the first inspection that finds one or more
violations at an outlet, regardless of the number of violations that
were noted and included in a Warning Letter. For any subsequent
inspections, CTP may count any or all violations, and its general
policy is to count each of them individually.
If the respondent does not agree with the allegations in a CMP
notice, wants to contest the amount of the CMP that FDA is seeking, or
has other concerns related to the case, the party may file an answer.
At that time, the respondent may request settlement discussions with
FDA. Settlement discussions are often an efficient method of resolving
a contested case. The respondent may present evidence and arguments as
to why the party should not be liable for a CMP, or mitigating factors
that should reduce the amount of the CMP. If the respondent and FDA do
not agree on a settlement, the respondent may still have a hearing. If
the respondent is not satisfied with the decision at a hearing, the
respondent has a right to appeal the initial decision to the
Departmental Appeals Board (DAB) by filing a notice of appeal with the
DAB and the FDA Division of Dockets Management within 30 days of the
relevant decision.
In an effort to provide information to retailers and other
interested stakeholders regarding the issuance of CMPs for violations
of the FD&C Act requirements relating to tobacco products in retail
outlets, FDA has issued two guidance documents (``Civil Money Penalties
for Tobacco Retailers: Responses to Frequently Asked Questions'' and
``Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco
Retailers'') and has provided at least three compliance training
webinars that covered the topic of CMPs.
Question 2. The Family Smoking Prevention legislation was set up to
create incentives for voluntary compliance by retailers by, for
example, providing for a smaller set of penalties for retailers that
have compliance programs that include using an approved training
program. However, it is my understanding that CTP has not yet approved
a single training program. I'm hearing from retailers that without that
approval it is hard for them to justify the investment in training that
they would like to make. Can you tell me when CTP will approve one or
more training programs so that retailers know which ones they should
use to best comply with the law?
Answer 2. Retailers are encouraged to implement a training program
for their staffs and to tailor their programs to meet the needs of
their employees and businesses, taking into consideration the size of
their businesses and the products they sell.
FDA understands that some retailers have established various
tobacco retailer training programs. FDA does not currently approve any
retailer training program. FDA intends to promulgate regulations
establishing standards for approved retailer training programs. The TCA
also establishes two schedules for the maximum civil money penalties
that can be assessed for violations of regulations issued under section
906(d) of the FD&C Act, including violations of FDA regulations at 21
CFR part 1140--one schedule for retailers that do not have an approved
training program, and another with lower penalties for retailers with
an approved training program. In determining the amount of the penalty
the Agency will seek, CTP will use the lower schedule for all
retailers, whether or not the retailer has implemented a training
program, until regulations are developed that establish standards for
retailer training programs. FDA has also issued a guidance entitled
``Guidance for Industry: Tobacco Retailer Training Programs,'' which is
available at www.fda.gov/TobaccoProducts/GuidanceCompliance Regulatory
information/ucm218898.htm. This guidance contains examples of
recommended elements that may be helpful to retailers when designing
and implementing a training program.
Currently, FDA develops compliance training materials for
retailers, posts important information to its Web site, issues guidance
documents, meets with and presents before stakeholders, and has
established a comprehensive program for training on, and assistance
with, the requirements of the Act. In fiscal year 2014, CTP delivered
five compliance training webinars for retailers and small businesses
covering topics relevant to tobacco product businesses. In addition,
FDA is developing a new retailer education campaign and will continue
to provide easy-to-understand, free educational materials online and by
direct mail that help tobacco retailers comply with the law. The
campaign currently provides materials in English and Spanish and plans
to expand to include additional languages in fiscal year 2015.
senator burr
Question 1. Do you believe that public health messaging with
respect to tobacco products should be based on science and reflect the
risk continuum of tobacco products?
Answer 1. Yes, to ensure that public health messaging is effective,
it should be grounded in solid science. To that end, FDA continues to
collaborate with CDC and NIH, and invests in research in the
development and evaluation of its public education efforts. At the same
time, scientific consensus is not required prior to disseminating
public health information.
FDA also recognizes that there is a continuum of tobacco products
with potential differences in risk, and the Agency will rely on sound
science to demonstrate the public health impact of new FDA-regulated
tobacco products. Many provisions of the TCA require FDA to make
decisions after considering the risks and benefits to the population as
a whole, including both users and non-users. A risk continuum is a
relevant consideration as we make regulatory policy. But the potential
patterns of use make this a challenging assessment. For example, in
addition to understanding the adverse health impact of a particular
product or regulatory action on tobacco product users, the Agency's
actions include consideration of the impact on non-users (including
youth) initiating tobacco use, the potential for delayed cessation, and
the potential for former smokers to resume tobacco use.
Question 2. What are the potential health benefits for individuals
moving from smoking conventional cigarettes to forms of non-combustible
tobacco products, including those with the goal of cessation as well as
those who would otherwise be using a combustible tobacco product?
Answer 2. FDA acknowledges that there may be products that contain
lower levels of toxicants than cigarettes. HHS, including CDC, FDA, and
NIH, are conducting studies that will assess the addictiveness and the
relative toxicities of e-cigarettes and other tobacco products.
However, under the TCA, FDA must make determinations about whether a
particular regulatory action or the marketing of a particular product
is appropriate for the protection of the public health based on a
population health standard. This means that FDA must consider the risks
and benefits to both users and non-users.
Thus, in addition to understanding the impact for smokers who
completely switch to a non-combustible tobacco product, the Agency
needs to understand the impact on youth and others initiating tobacco
use, smokers continuing to smoke while using the non-combustible
product, the potential for delayed cessation of smoking, and the
potential for former smokers to resume tobacco use. Products marketed
for therapeutic purposes, such as FDA-approved smoking cessation
products, would continue to be regulated under the safety and efficacy
standard that currently exists for drugs and devices. They would not be
regulated as tobacco products.
Question 3. Will FDA take into consideration the scientific
evidence comparing the health impact of vaping compared to combustible
tobacco cigarettes? Please describe any scientific theory or current
evidence that e-cigarettes are as hazardous as, or more hazardous than,
combustible tobacco cigarettes.
Answer 3. The tobacco marketplace is changing rapidly, with new
types and brands of tobacco products increasing at a faster pace than
ever before. The resulting prospect of consumers exploring and adopting
use of new products is prompting tobacco control experts, scientists,
and regulators to consider how to best evaluate, monitor, regulate, and
communicate to the public about these products in order to protect the
public health.
E-cigarettes have become a significant source of nicotine in this
new tobacco use environment. Awareness of e-cigarettes among U.S.
adults doubled between 2009 and 2011. Adolescent use increased between
2011 and 2014. According to the University of Michigan's Monitoring the
Future study, in 2014, 9 percent of 8th graders reported using an e-
cigarette in the past 30 days, 16 percent of 10th graders, and 17
percent of 12th graders.
Much remains to be learned about the risks of e-cigarettes to
health, as well as their possible benefits. E-cigarettes could be a
detriment to public health. E-cigarettes have the potential to re-
normalize smoking, encourage youth to initiate smoking, and/or prompt
users to continue or to escalate to cigarette use--in effect, reversing
the meaningful progress tobacco control initiatives have achieved to
date. Other reported e-cigarette risks include dermal exposure to
nicotine, childhood poisoning events, and physical harm from defective
products (such as exploding batteries). On the other hand, e-cigarettes
could benefit public health if they encourage people who would
otherwise not quit smoking to stop smoking altogether, while not
encouraging youth or others to start use of tobacco products or
encouraging former users to relapse back to tobacco use. Anecdotes
illustrating both harms and benefits abound, but it is definitive
scientific evidence that should drive the actions taken with respect to
e-cigarettes.
CTP has identified e-cigarettes as an immediate research priority
area, and since 2012 has funded 50 research projects to better
understand e-cigarette initiation, use, perceptions, dependence, and
toxicity. Research to address e-cigarette knowledge gaps is being
funded by grants administered through NIH and through internal FDA
research. This ongoing and funded research is likely to provide
characterization of some e-cigarette devices, e-liquids, and aerosols,
and a better understanding of e-cigarette users, reasons for use, abuse
liability, user perceptions, health effects, and topography. CTP
comprehensively assesses e-cigarette use among U.S. youth and adults
via the national tobacco surveillance systems in collaboration with the
CDC (National Youth Tobacco Survey (NYTS) and National Adult Tobacco
Survey (NATS)). CTP has also partnered with CDC's Pregnancy Risk Factor
Surveillance System (PRAMS) to track the prevalence of e-cigarette use
before, during and shortly after pregnancy, among women who have
recently given birth. An analysis of the totality of the data will be
needed to assess the impact of e-cigarettes on the public health.
Question 4. Is there a potential public health benefit at the
individual tobacco user level, as well as for the millions of
individuals, who may be seeking to transition from tobacco products
that present the greatest level of harm to products with a reduced or
lesser level of harm?
Answer 4. FDA recognizes that there is a continuum of tobacco
products with potentially different toxicity profiles, and will rely on
sound science to demonstrate the public health impact of new FDA-
regulated tobacco products. HHS, including CDC, FDA and NIH, are
conducting studies that will assess the addictiveness and the relative
toxicities of e-cigarettes and other tobacco products. Many provisions
of the TCA require FDA to make decisions about what is appropriate for
the protection of the public health after considering the risks and
benefits to the population as a whole, including both users and non-
users. A risk continuum is a relevant consideration as we make
regulatory policy. But the potential patterns of use make this a
challenging assessment. For example, in addition to understanding the
adverse health impact of a particular product on tobacco product users,
the Agency's actions include consideration of the likely impact on
youth or others initiating tobacco use, smokers continuing to smoke
while using the product, the potential for delayed cessation of
smoking, and the potential for former smokers to resume tobacco use.
Much remains to be learned about the risks of e-cigarettes to
health, as well as their possible benefits. E-cigarettes could be a
detriment to public health. E-cigarettes have the potential to re-
normalize smoking, encourage youth to initiate smoking, and/or prompt
users to continue or to escalate to cigarette use--in effect, reversing
the meaningful progress tobacco control initiatives have achieved to
date. Other reported e-cigarette risks include dermal exposure to
nicotine, childhood poisoning events, and physical harm from defective
products (such as exploding batteries). On the other hand, e-cigarettes
could benefit public health if they encourage people who would
otherwise not quit smoking to stop smoking altogether, while not
encouraging youth or others to start use of tobacco products or
encouraging former users to relapse back to tobacco use.
Question 5. Is FDA committed to ensuring that the Agency's
regulation of tobacco products will ensure that consumers have timely
access to innovative products that present less harm to them than
combustible tobacco cigarettes?
Answer 5. FDA's proposed rule to extend its tobacco product
authorities to additional products that meet the statutory definition
of ``tobacco product'' demonstrates the Agency's sensitivity to the
importance of innovation. FDA has proposed an extended compliance
period for manufacturers of newly deemed products to submit their
marketing applications. In addition, for products with applications
submitted in that compliance period, FDA has indicated the Agency 's
intent to continue the compliance period and not initiate enforcement
action against products on the market for failing to have marketing
authorization, pending FDA's review of the application.
FDA has also specifically solicited suggestions on other actions/
approaches that the Agency could take to address this issue. The
proposed deeming rule also acknowledges that there exists a continuum
of nicotine-delivering products that may pose different levels of risk
to the individual. We pose a series of questions in the rule, and
sought comment on how this continuum should impact regulatory policy
going forward, once the final rule is in effect.
Question 6. FDA received seven modified-risk tobacco product
pathway applications, but it is my understanding that FDA refused to
accept six of these applications. Please provide FDA's reasoning for
refusing to accept each of these six applications. How is FDA ensuring
that applicants have clear guidance with respect to the requirements
that need to be met in order for FDA to accept these applications for
review?
Answer 6. When FDA receives a modified-risk tobacco product (MRTP)
application, it will first determine whether the application can be
accepted and filed for substantive review. For example, if the
application is for a product that is not a ``tobacco product,''or is
for a tobacco product that is not currently regulated by FDA, or FDA is
unable to review and process the application, the Agency may refuse to
accept it. If the application is accepted, FDA will conduct a filing
review to determine whether the application is complete, i.e., whether
it contains all the items required under Section 911(d) of the FD&C
Act. If the application is incomplete, FDA may refuse to file it. If
the application is complete, FDA will file the application and begin a
substantive review.
As of September 30, 2014, FDA has received multiple MRTP
applications. Ten of these applications have been filed by FDA and are
currently undergoing scientific review. FDA issued refuse-to-accept
letters for two applications and refuse-to-file letters for four
applications, because they failed to include information required under
the TCA and/or were about products that CTP does not currently
regulate. One application was withdrawn by the applicant.
A draft guidance was released for public comment in March 2012,
containing information about submitting applications for MRTPs. The
draft guidance addresses topics such as how to organize and submit an
application, what scientific studies and analyses could be submitted,
and what information could be collected through post-market
surveillance and studies.\5\ FDA has also been meeting with individual
manufacturers to discuss studies the manufacturers have proposed to
demonstrate that marketing authorization for a product is appropriate
under section 911 of the FD&C Act.
---------------------------------------------------------------------------
\5\ ``Draft Guidance for Industry: Modified Risk Tobacco Product
Applications.'' 77 Fed. Reg. 20026 (published for comments on April 3,
2012).
Question 7. By what date does FDA intend to finalize its draft
guidance on modified-risk tobacco product requirements?
Answer 7. FDA is currently reviewing comments on the draft guidance
on MRTP applications, but is not able to provide a specific date for
finalization.\6\ FDA is committed to helping industry better understand
the tobacco product review process and the requirements in the law
related to MRTP, and plans to continue meeting with stakeholders as
needed to answer specific questions.
---------------------------------------------------------------------------
\6\ Section 911(1)(l) of the FD&C Act directs FDA to issue
regulations or guidance (or any combination thereof) on the scientific
evidence required for assessment and ongoing review of modified-risk
tobacco products. FDA issued this draft guidance in compliance with
section 911(1)(l). See 77 FR 20026 at 20027 (April 3, 2012).
http:www.gpo.gov/(dsys/pkg/FR-2012-04-03/pdf/2012-7908.pdf.
Question 8. Last fall, GAO issued a report that found that as of
late June 2013, CTP had made a final decision on only 6 of the 3,788
substantial equivalent submissions, with the remaining submissions
still undergoing CTP review. In this same report, GAO recommended that
FDA establish performance measures that include timeframes for making
decisions on new tobacco product submissions and monitor performance
relative to those timeframes. Last month, GAO testified that as of
December 31, 2013, CTP had made final decisions for only 30 of the
4,490 SE submissions the agency had received. Will CTP set a
performance target for provisional SE submissions to mitigate the
current backlog of submissions? If so, please provide the performance
goals and targets for clearing CTP's current backlog. If not, please
explain why the Agency will not apply any performance metrics to these
submissions.
SE reports fall into two categories. One category is
``provisional'' SE reports that apply to new products introduced to
market between February 15, 2007, and March 22, 2011, and for which SE
reports were submitted to FDA by March 22, 2011. These products can
remain on the market unless FDA finds they are NSE. The other category
is ``regular'' SE reports (reports for new products submitted after
March 22, 2011). Tobacco products subject to a regular SE report may
not be marketed unless FDA issues an order that the tobacco product is
substantially equivalent and in compliance with the requirements of the
FD&C Act. In April 2014, CTP established performance measures that
include timeframes for review of regular SE reports. These performance
measures were implemented on October 1, 2014.
CTP has begun review of provisional SE reports and issued the first
decisions on these reports on February 21, 2014. As provisional SE
reports were submitted very early in the history of the review process,
they were submitted before applicants had the knowledge and experience
gained over the last few years. Thus, provisional SE reports are likely
to be less well-organized, have many more deficiencies, and require a
more complicated review by FDA than SE reports for regular products
that are now being submitted. The potential for both large numbers of
deficiencies and varying quality of provisional SE reports prevents FDA
from predicting the time necessary for completing the initial review
and for making a final decision. While it is important that FDA makes
review decisions about tobacco products in a timely manner, it is
absolutely critical that these marketing decisions are sound, grounded
in the best available science, and made in accordance with applicable
public health standards. Once FDA has had more experience addressing
provisional SE reports, we expect to better understand the time that
will be needed to review individual reports. At that time, we intend to
set performance goals for provisional SE reports.
Question 9. How does CTP propose to uphold its responsibility to
review products in a timely manner given the potential impact the
proposed deeming rule on CTP's current backlog of submissions? Will CTP
establish performance goals and timelines to balance the current
backlog of submissions with any additional workload as a result of the
two options proposed with respect to cigars and other products under
the proposed deeming rule? If so, please provide details.
Answer 9. On March 24, 2014, CTP announced that we no longer have a
backlog of regular SE reports awaiting review and that the Center is
starting review on regular SE reports as they are received. As of
September 30, 2014, 45 percent of regular SE reports had been resolved
by a final decision\7\ either because FDA issued an Order letter,
issued a Refuse-to-Accept letter or because the submission was
withdrawn. FDA has issued a Scientific Advice and Information Request
Letter or a Preliminary Finding Letter for 81 percent of the regular SE
reports that are pending.
---------------------------------------------------------------------------
\7\ Final decisions include Refuse-to-Accept letters, withdrawals
by an applicant, substantially equivalent (SE) orders, not
substantially equivalent (NSE) orders.
---------------------------------------------------------------------------
CTP established four performance goals that include timeframes for
review of regular SE reports, review of Exemption from SE requests, and
review of MRTP applications (see tables below). Beginning on October I,
2014, tracking of all goals was implemented.
Regulatory Performance Measures
Substantial Equivalence Reports for products currently regulated by
FDA (cigarettes, cigarette tobacco, smokeless tobacco, roll-your-own
tobacco)
------------------------------------------------------------------------
Submission cohort
Category Performance goal (In percent)
------------------------------------------------------------------------
Regular SE Reports.............. Finalize Fiscal year 2015:
jurisdiction and 50
completeness Fiscal year 2016:
review (and issue 60
letter as Fiscal year 2017:
appropriate) 70
within 21 days of Fiscal year 2018:
FDA receipt of SE 80
Report.
Review and act on Fiscal year 2015:
an original SE 50
Report within 90 Fiscal year 2016:
days of FDA 60
receipt. Fiscal year 2017:
70
Fiscal year 2018:
80
Regular SE Report Resubmissions. Review and act on Fiscal year 2015:
a SE Report 50
resubmission Fiscal year 2016:
within 90 days of 60
FDA receipt. Fiscal year 2017:
70
Fiscal year 2018:
80
------------------------------------------------------------------------
Exemption from SE Requests for products currently regulated by FDA
(cigarettes, cigarette tobacco, smokeless tobacco, roll-your-own
tobacco)
------------------------------------------------------------------------
Submission cohort
Category Performance goal (In percent)
------------------------------------------------------------------------
Exemption from SE............... Review and act on Fiscal year 2015:
a Request for 50
Exemption from SE Fiscal year 2016:
within 60 days of 60
FDA receipt. Fiscal year 2017:
70
Fiscal year 2018:
80
------------------------------------------------------------------------
Modified-Risk Tobacco Product Applications (MRTPA) for products
currently regulated by FDA (cigarettes, cigarette tobacco, smokeless
tobacco, roll-your-own tobacco)
------------------------------------------------------------------------
Submission cohort
Category Performance goal (In percent)
------------------------------------------------------------------------
MRTPA........................... Review and act on Fiscal year 2015:
a complete MRTP 50
application Fiscal year 2016:
within 360 days 60
of FDA receipt. Fiscal year 2017:
70
Fiscal year 2018:
80
------------------------------------------------------------------------
For purposes of the regulatory performance measures listed above:
``Review and act on'' means issuance of a letter (e.g.,
Scientific Advice and Information Letter, Preliminary Finding Letter,
NSE or SE Order) after the review of an accepted regular SE report or
resubmission; issuance of an order or letter after the review of an
exemption from SE request; or the issuance of an order or letter after
the complete review of a filed MRTP application. This timetable for
MRTPs is FDA's best estimate, but it is based on limited information.
``Issue letter as appropriate'' means the issuance of an
Acknowledgement Letter or Refuse-to-Accept Letter. If acknowledged, and
the administrative review notes missing information, the information
will be addressed during scientific review.
Scientific Advice and Information Letter or Preliminary
Finding Letter means a written communication, which lists deficiencies
in an SE Report that precludes either further scientific review or
issuance of an SE Order.
FDA has made significant progress in reviewing SE reports for
currently regulated products and this momentum will continue. The
Center has increased staffing, taken steps to streamline the SE review
process, and established the performance measures above that include
timeframes for review of regular SE reports and review of exemption
from SE requests. We have been able to develop these performance goals
because of increased capacity, efficiency, and knowledge of the
scientific evidence needed to adequately review SE reports.
FDA plans to continue increasing staffing, strengthening our IT
systems, and developing guidance and/or regulations to clarify
submission requirements. As FDA and industry gain experience with
submissions for these newly deemed products, we intend to identify and
implement performance goals for these submissions.
CTP is committed to a consistent, transparent, and predictable
review process and to completing reviews in a timely manner.
senator casey
Question 1. There are an increasing number of cases of children who
have been poisoned from electronic cigarette refill vials. In April,
the CDC warned that the number of calls to poison control centers for
nicotine poisoning from electronic cigarettes has increased
dramatically. More than half of these calls involved children age 5 or
under. What, if any, steps does the FDA feel would be appropriate to
address this issue? Does the FDA plan to begin collecting data on this
matter or propose a regulation to require childproof refill vials if
the current deeming regulation is approved?
Answer 1. In the preamble to the proposed deeming rule, FDA
included discussion regarding the recent increased incidence of child
nicotine poisoning and the Agency's concerns regarding this issue. FDA
considers the deeming rule to be a foundational regulation, which, when
finalized, would allow the Agency to take further actions regarding
critical issues, such as protecting children from liquid nicotine,
related to the proposed deemed products. For example, FDA would have
authority to issue tobacco product manufacturing practice regulations
under section 906(e) of the FD&C Act. Such regulations could include
requirements regarding the packaging and storage of tobacco product
such as liquid nicotine. In addition, under section 907 of the FD&C
Act, FDA would have authority to issue a product standard with
provisions related to components of tobacco products, such as liquid
nicotine refill cartridges. Sections 906(d) and 907(a)(4)(B)(v) also
afford FDA the authority to issue regulations restricting the sale and
distribution of a tobacco product, if FDA determines that such a
regulation would be appropriate for the protection of the public
health.
Question 2. In your testimony, you discuss the partnerships the CTP
has formed with organizations such as the NIH and the CDC to advance
the regulatory science base for tobacco products. What, if any, impact
did sequester cuts to institutions like the NIH and the CDC have on
those efforts? Is there any research that is not being done or that is
being delayed because of a lack of adequate funding?
Answer 2. Congress designed CTP's financial structure to depend, in
part, on carryover funding, so it made CTP's tobacco fees available
until expended. This made it possible for FDA to limit the impact of
sequestration in fiscal year 2013 on the TCA. FDA successfully worked
with institutions such as NIH and CDC to ensure that activities funded
with tobacco user fees were able to continue.
[Whereupon, at 4:59 p.m., the hearing was adjourned.]